FDA Adverse Event
Summary report: N
MANUAL ORTHOPEDIC SURGICAL INSTRUMENT
MDR report key: 3042268
·
Received April 9, 2013
Report
- Report Number
- 1030489-2013-00949
- Date Received
- April 9, 2013
- Date of Event
- March 8, 2013
- Report Date
- March 11, 2013
- Manufacturer
- MEDTRONIC SOFAMOR DANEK USA, INC
- Product Code
- LXH
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR SPINAL SURGICAL PROCEDURE. IT WAS REPORTED THAT THE DRIVER TIP BROKE OFF. THE TIP COULD NOT BE REMOVED FROM THE SCREW AND REMAINED IN THE PATIENT. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 145406 | MANUAL ORTHOPEDIC SURGICAL INSTRUMENT | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | LXH | MEDTRONIC SOFAMOR DANEK USA, INC | NA | PU11K001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00015 YR | Other |