FDA Adverse Event
Malfunction
Summary report: N
NEURO SCREWS, CROSS-PIN, SELF-DRILLING, DIAM.1.5X5
MDR report key: 2181143
·
Received July 8, 2011
Report
- Report Number
- 8010177-2011-00195
- Event Type
- Malfunction
- Date Received
- July 8, 2011
- Date of Event
- June 10, 2011
- Report Date
- June 15, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS FREIBURG
- Product Code
- JEY
- PMA / PMN Number
- K031659
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IN PROGRESS, BUT NOT YET COMPLETE.
Description of Event or Problem · 1
SCREW HEAD DISASSEMBLED FROM SCREW BODY DURING CRANIOTOMY. THE THREAD PORTION OF THE SCREW WAS LEFT IN THE PT, BUT THE HEAD PORTION IS AVAILABLE FOR RETURN. CASE OCCURRED ON (B)(6), BUT SALES REP WAS INFORMED OF IT ON (B)(6). NO OTHER INFO IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEURO SCREWS, CROSS-PIN, SELF-DRILLING, DIAM.1.5X5 | IMPLANT | JEY | STRYKER OSTEOSYNTHESIS FREIBURG | NA | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |