FDA Adverse Event
Malfunction
Summary report: N
OPTIMIZED TIMESH SELF DRILL SCREW, 4.0MM
MDR report key: 1960359
·
Received December 16, 2010
Report
- Report Number
- 2021898-2010-00352
- Event Type
- Malfunction
- Date Received
- December 16, 2010
- Date of Event
- October 28, 2010
- Report Date
- November 16, 2010
- Manufacturer
- MEDTRONIC NEUROSURGERY
- Product Code
- JEY
- PMA / PMN Number
- K973145
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE HAS NOT BEEN RETURNED TO THE MFR. A REVIEW OF THE MFG RECORDS WAS NOT POSSIBLE, AS NO LOT NUMBER WAS PROVIDED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SCREW BROKE DURING SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OPTIMIZED TIMESH SELF DRILL SCREW, 4.0MM | JEY | MEDTRONIC NEUROSURGERY | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |