FDA Adverse Event
Malfunction
Summary report: N
CRESCENT SPINAL SYSTEM
MDR report key: 2872607
·
Received December 13, 2012
Report
- Report Number
- 1030489-2012-02800
- Event Type
- Malfunction
- Date Received
- December 13, 2012
- Date of Event
- November 15, 2012
- Report Date
- November 15, 2012
- Manufacturer
- MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
- Product Code
- MAX
- PMA / PMN Number
- K094025
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNSPECIFIED SPINAL PROCEDURE. IT WAS REPORTED THAT DURING THE PROCEDURE, THE IMPLANT C RACKED AND BROKE DURING INSERTION. ALL FRAGMENTS WERE REMOVED FROM THE PATIENT AND ANOTHER IMPLANT WAS USED. NO PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CRESCENT SPINAL SYSTEM | INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR | MAX | MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS | NA | H11K3673 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |