FDA Adverse Event
Malfunction
Summary report: N
DELTA V-40 CERAMIC HEAD 36/0
MDR report key: 2823912
·
Received October 10, 2012
Report
- Report Number
- 9616680-2012-00865
- Event Type
- Malfunction
- Date Received
- October 10, 2012
- Date of Event
- September 18, 2012
- Report Date
- September 18, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- LZO
- PMA / PMN Number
- K052718
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
DURING THE SURGERY, A SCRATCH WAS FOUND ON THE SURFACE OF THE DEVICE RIGHT AFTER THE DEVICE WAS PICKED UP FROM THE PACKAGE. A BACKUP DEVICE WAS USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DELTA V-40 CERAMIC HEAD 36/0 | IMPLANT | LZO | STRYKER ORTHOPAEDICS CORK | NA | 40828703 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |