FDA Adverse Event
Other
Summary report: N
NCB CANNULATED SCREW, 4.0MM DIAMETER, 28MM
MDR report key: 3240827
·
Received July 18, 2013
Report
- Report Number
- 9613350-2013-01746
- Event Type
- Other
- Date Received
- July 18, 2013
- Date of Event
- July 12, 2013
- Report Date
- July 12, 2013
- Manufacturer
- ZIMMER GMBH
- Product Code
- HWC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
AS THE REPORTED EVENT WAS FLAGGED BEFORE DELIVERY TO CUSTOMERS, THE REMAINING QUANTITIES HAS BEEN QUARANTINED AS PER LOCAL PROCEDURE. AN UPDATED REPORT WILL BE SUBMITTED WHEN FURTHER INFO IS RECEIVED. ZIMMER REFERENCE NUMBER (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE NCB SCREW IN PACKAGING WAS NOT CANNULATED. ISSUE WAS FLAGGED AT ZIMMER WAREHOUSE, PRIOR TO DELIVERY TO CUSTOMER. REMAINING QUANTITIES HAVE BEEN QUARANTINED AS PER LOCAL PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 336435 | NCB CANNULATED SCREW, 4.0MM DIAMETER, 28MM | NCB PLANTING SYSTEM | HWC | ZIMMER GMBH | 2713121 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |