FDA Adverse Event
Malfunction
Summary report: N
CRESCENT SPINAL SYSTEM
MDR report key: 5928277
·
Received September 6, 2016
Report
- Report Number
- 1030489-2016-02481
- Event Type
- Malfunction
- Date Received
- September 6, 2016
- Date of Event
- July 13, 2016
- Report Date
- September 6, 2016
- Manufacturer
- MSD DEGGENDORF MFG
- Product Code
- MAX
- PMA / PMN Number
- SEE H10
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ANALYSIS: ONLY ONE SMALL PORTION OF THE IMPLANT RETURNED FOR ANALYSIS. MICROSCOPIC FRACTURE SURFACE EXAMINATION IDENTIFIED RAYS EMANATING FROM THE ONE CORNER OF THE IMPLANT SURFACE. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH BRITTLE OVERLOAD.
Additional Manufacturer Narrative · 1
THIS PRODUCT IS NOT APPROVED FOR SALE IN US BUT A SIMILAR PRODUCT WITH CATALOG NUMBER 9393608 AND 510K# K094025 IS APPROVED FOR SALE IN US. THE PRODUCT IS NOT RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE CAUSE OF EVENT CANNOT BE DETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNSPECIFIED SPINAL SURGERY. DURING SURGERY, THE CAGE BROKE. PATIENT COMPLICATIONS WERE REPORTED UNKNOWN. NO FURTHER INFORMATION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 579616 | CRESCENT SPINAL SYSTEM | INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR | MAX | MSD DEGGENDORF MFG | NA | 29BT |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |