FDA Adverse Event
Injury
Summary report: N
UNKNOWN_SELZACH_PRODUCT
MDR report key: 4877014
·
Received June 29, 2015
Report
- Report Number
- 0008031020-2015-00266
- Event Type
- Injury
- Date Received
- June 29, 2015
- Date of Event
- June 2, 2015
- Report Date
- June 2, 2015
- Manufacturer
- STRYKER TRAUMA SELZACH
- Product Code
- NTG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE REPORTED DEVICE WAS MANUFACTURED AND DISTRIBUTED BY SMALL BONE INNOVATION, INC., (B)(6) AND IMPLANTED PRIOR TO HOWMEDICA OSTEONICS CORP.¿S PURCHASE OF CERTAIN ASSETS OF SBI ON (B)(4) 2014. STRYKER BECAME LEGAL MANUFACTURER OF THIS PRODUCT ON APRIL 1, 2015 AND HAS TAKEN THE RESPONSIBILITY FOR MEDICAL DEVICE REPORTING. DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
THE SALES REP WAS NOTIFIED THAT A PATIENT UNDERWENT A REVISION SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 417914 | UNKNOWN_SELZACH_PRODUCT | IMPLANT | NTG | STRYKER TRAUMA SELZACH | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |