FDA Adverse Event
Malfunction
Summary report: N
HANSSON PIN STST 110MM
MDR report key: 2050578
·
Received March 15, 2011
Report
- Report Number
- 8031020-2011-00066
- Event Type
- Malfunction
- Date Received
- March 15, 2011
- Date of Event
- February 14, 2011
- Report Date
- February 25, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS SELZACH
- Product Code
- HTY
- PMA / PMN Number
- K033968
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADD'L INFO HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED; ANY ADD'L INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
THE CUSTOMER REPORTS VIA OUR SALES REP, THAT THE THREAD WAS LOOSE AND THE LIP COULD NOT BE MOVED OUTWARDS. SHE FURTHER REPORTS THAT THE SURGERY WAS FINISHED WITH SLIGHT DELAY USING A DIFFERENT PIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HANSSON PIN STST 110MM | IMPLANT | HTY | STRYKER OSTEOSYNTHESIS SELZACH | NA | S93287 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |