FDA Adverse Event
Malfunction
Summary report: N
9 X 35MM BIOABSORBABLE WEDGE INTERFERENCE SCREW
MDR report key: 1190608
·
Received October 3, 2008
Report
- Report Number
- 2936485-2008-00081
- Event Type
- Malfunction
- Date Received
- October 3, 2008
- Date of Event
- February 25, 2008
- Report Date
- September 5, 2008
- Manufacturer
- STRYKER ENDOSCOPY SAN JOSE
- Product Code
- MAI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SCREW BROKE DURING A SURGICAL TECHNIQUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9 X 35MM BIOABSORBABLE WEDGE INTERFERENCE SCREW | BIOABSORBABLE SCREW | MAI | STRYKER ENDOSCOPY SAN JOSE | 55674 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |