Devices: Coloplast Genesis, Boston Scientific Tactra
Source:
-U.S. Food and Drug Administration
https://www.fda.gov/medical-devices/med ... data-files
-AI tools for a high level summary
Overall
- Total malleable reports in this set: 10
- Coloplast Genesis: 2
- Boston Scientific Tactra: 8
Coloplast GENESIS (2 reports)
- Both reports involve impending erosion leading to explant and replacement with another implant.
- In 1/2 reports the erosion is described as “impending distal erosion”.
- In 1/2 reports the case is identified as a gender-affirmation case.
- For both: implant date unknown, no lot number, device not returned → no DHR/complaint/CAPA evaluation possible.
Boston Scientific TACTRA (8 reports)
1. Mechanical fracture (structural failure) – 2/8
- 1 report: device fractured in half; removed surgically; no additional complications reported.
- 1 report: single cylinder fracture at the ischiopubic ramus bone-anchor site; fractured cylinder removed and replaced with a new Tactra cylinder; no further complications reported.
2. Sizing/positioning / functional dissatisfaction – 3/8
- 1 report: prosthesis not properly sized and positioned; corrective surgery performed; no complications.
- 1 report: device removed and replaced due to patient dissatisfaction with how it was positioned and felt; no complications reported.
- 1 report: patient felt device was too short with a floppy distal end, making it difficult to use; device remains implanted, follow-up scheduled. Manufacturer classifies the disfigurement as a known inherent risk per the IFU.
3. Surgery/revision for unspecified reasons – 3/8
- 3 reports: patients underwent Tactra surgery/replacement for unspecified reasons; in at least 1 of these, a new Tactra was implanted.
- In all three, manufacturer notes that detailed product information was not provided; device is described as “product unknown”, with full UDI and product-specific data unavailable despite a “good faith effort” to obtain it.
Mechanical vs non-mechanical breakdown (within this 10-report set)
- Clearly mechanical device fracture: 2/10 (both Tactra).
- Erosion leading to explant: 2/10 (both Genesis; impending erosion, one explicitly distal).
- Sizing/positioning / dissatisfaction / functional concerns without fracture: 4/10 (all Tactra).
- Revisions for unspecified reasons: 3/10 (all Tactra).
