FDA Adverse Event
Malfunction
Summary report: N
MULT DRILL GUIDE 3.2MM
MDR report key: 2020018
·
Received March 9, 2011
Report
- Report Number
- 8031020-2011-00063
- Event Type
- Malfunction
- Date Received
- March 9, 2011
- Date of Event
- February 21, 2011
- Report Date
- February 22, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS SELZACH
- Product Code
- LXH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FI
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT. SAME PT EVENT AS MDR 8031020-2011-00064.
Description of Event or Problem · 1
THE NURSE INFORMED PRODUCT MANAGER THAT PRODUCTS ARE DIFFICULT TO LOCK AND UNLOCK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MULT DRILL GUIDE 3.2MM | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS SELZACH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |