FDA Adverse Event
Injury
Summary report: N
MANUAL ORTHOPEDIC SURGICAL INSTRUMENT
MDR report key: 1994072
·
Received February 16, 2011
Report
- Report Number
- 1030489-2011-00137
- Event Type
- Injury
- Date Received
- February 16, 2011
- Date of Event
- January 18, 2011
- Report Date
- January 18, 2011
- Manufacturer
- MEDTRONIC SOFAMOR DANEK
- Product Code
- LXH
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, 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 AN ANTERIOR CERVICAL FUSION. IT WAS REPORTED THAT DURING REMOVAL, THE DISTAL TIP OF THE PREFIXATION PIN BROKE OFF AND WAS LEFT CONTAINED WITHIN THE PLATE 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 | PIN, FIXATION, SMOOTH | LXH | MEDTRONIC SOFAMOR DANEK | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | PLATE |