FDA Adverse Event
Malfunction
Summary report: N
LOCKING SCREW NUMELOCK II 6.5X75MM
MDR report key: 2003067
·
Received February 8, 2011
Report
- Report Number
- 8031020-2011-00027
- Event Type
- Malfunction
- Date Received
- February 8, 2011
- Date of Event
- January 18, 2011
- Report Date
- January 24, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS SELZACH
- Product Code
- KTT
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED WILL BE SUBMITTED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
DURING SURGERY WHEN THE SURGEON OPENED THE PACKAGE, THE PLASTIC PACKAGING WAS BROKEN. THE STERILITY WAS NOT COMPROMISED. THE SURGEON USED OTHER PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LOCKING SCREW NUMELOCK II 6.5X75MM | IMPLANT | KTT | STRYKER OSTEOSYNTHESIS SELZACH | NA | N21470 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |