FDA Adverse Event
Injury
Summary report: N
MANUAL ORTHOPEDIC SURGICAL INSTRUMENT
MDR report key: 2020647
·
Received March 16, 2011
Report
- Report Number
- 1030489-2011-00285
- Event Type
- Injury
- Date Received
- March 16, 2011
- Date of Event
- February 7, 2011
- Report Date
- February 15, 2011
- Manufacturer
- MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING
- Product Code
- LXH
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
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 LUMBAR SPINAL FUSION AT L3-S1. IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF INTO THE SCREW AND WAS NOT ABLE TO BE REMOVED FROM THE BONE SCREW. THE BONE SCREW WAS LEFT IN THE PATIENT. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MANUAL ORTHOPEDIC SURGICAL INSTRUMENT | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | LXH | MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | BONE SCREW |