FDA Adverse Event
Malfunction
Summary report: N
CRESCENT SPINAL SYSTEM
MDR report key: 6126720
·
Received November 24, 2016
Report
- Report Number
- 1030489-2016-03239
- Event Type
- Malfunction
- Date Received
- November 24, 2016
- Date of Event
- September 29, 2016
- Report Date
- November 9, 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
THIS PRODUCT IS NOT APPROVED FOR SALE IN U.S. BUT A SIMILAR PRODUCT WITH CATALOG NO. 9393608 AND 510K # K094025 (UPN: (B)(4)) IS APPROVED FOR SALE IN U.S. THE PRODUCT IS NOT RETURNED TO MANUFACTURER FOR EVALUATION; THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION. INTRA-OP, TIP OF CAGE BROKE. PATIENT COMPLICATIONS WERE REPORTED UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 777734 | CRESCENT SPINAL SYSTEM | INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR | MAX | MSD DEGGENDORF MFG | NA | 22CE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |