FDA Adverse Event
Other
Summary report: N
CBS MICRO COMP SCR 12 MM CANN
MDR report key: 4544350
·
Received February 23, 2015
Report
- Report Number
- 9613350-2015-00253
- Event Type
- Other
- Date Received
- February 23, 2015
- Date of Event
- January 22, 2015
- Report Date
- January 22, 2015
- Manufacturer
- NORMED MEDIZIN-TECHNIK GMBH
- Product Code
- HWC
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE MANUFACTURER HAS NOT YET RECEIVED DEVICES FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED ON (B)(6) 2015, THAT THE HOSPITAL COMPLAINED THAT 2 PACKAGES OF CBS MICRO COMP SCR 12 MM CANN CONTAINED SCREW WITH WRONG SIZE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 126572 | CBS MICRO COMP SCR 12 MM CANN | CBS MICRO COMPRESSION SCREW | HWC | NORMED MEDIZIN-TECHNIK GMBH | NA | 15180 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |