FDA Adverse Event
Injury
Summary report: N
VEPTR IMPLANT
MDR report key: 1002536
·
Received February 26, 2008
Report
- Report Number
- 2520274-2008-00013
- Event Type
- Injury
- Date Received
- February 26, 2008
- Report Date
- January 30, 2008
- Manufacturer
- SYNTHES (USA)
- Product Code
- MDI
- PMA / PMN Number
- NI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADD'L INFO HAS BEEN REQUESTED. CANNOT BE DETERMINED WITHOUT A PART NUMBER. SYNTHES IS UNABLE TO DETERMINE THE MFG DATE WITHOUT A LOT NUMBER. NO INVESTIGATION COULD BE PERFORMED, NO CONCLUSION DRAWN, AS NO DEVICE WAS RETURNED.
Description of Event or Problem · 1
SURGEON REPORTED INFECTION AT LEFT LATERAL VEPTS IMPLANT. PT WAS TAKEN TO OR TO HAVE WOUND DEHISCED AND LEFT LATERAL VEPTR IMPLANT REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VEPTR IMPLANT | VEPTR IMPLANT | MDI | SYNTHES (USA) | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 3 YR | Required Intervention |