FDA Adverse Event
Injury
Summary report: N
ZEPHIR ANTERIOR CERVICAL PLATE SYSTEM
MDR report key: 2112427
·
Received June 3, 2011
Report
- Report Number
- 1030489-2011-00662
- Event Type
- Injury
- Date Received
- June 3, 2011
- Report Date
- May 6, 2011
- Manufacturer
- MEDTRONIC SOFAMOR DANEK
- Product Code
- KWP
- PMA / PMN Number
- UNK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, 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 ONE LEVEL ANTERIOR CERVICAL DISCECTOMY FUSION. SOMETIME POST-OP IT WAS FOUND THAT THE SCREW HAD BACKED OUT. THE HARDWARE WAS REMOVED FROM THE PATIENT; NO REPLACEMENTS WERE NEEDED SINCE FUSION OCCURRED. NO PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZEPHIR ANTERIOR CERVICAL PLATE SYSTEM | KWP | MEDTRONIC SOFAMOR DANEK | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |