FDA Adverse Event
Malfunction
Summary report: N
WAVE CAGE OBLIQUE 11 X 26MM, 6 DEG
MDR report key: 3172793
·
Received June 17, 2013
Report
- Report Number
- 3003529816-2013-00045
- Event Type
- Malfunction
- Date Received
- June 17, 2013
- Date of Event
- May 15, 2013
- Report Date
- May 16, 2013
- Manufacturer
- ADVANCED MEDICAL TECHNOLOGIES
- Product Code
- MAX
- PMA / PMN Number
- K121330
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(6). (B)(4). LOCATION: HOSPITAL. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SPINAL PROCEDURE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE IMPLANT HOLDER WOULDN'T HOLD THE CAGE. THE SURGEON COULDN'T SUCCESSFULLY REATTACH THE CAGE TO THE HOLDER AND HAD TO PUSH BY USING A HAMMER THUS CAUSING THE CAGE TO BREAK UPON INSERTION. NO FURTHER DETAILS ARE KNOWN AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 273880 | WAVE CAGE OBLIQUE 11 X 26MM, 6 DEG | INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR | MAX | ADVANCED MEDICAL TECHNOLOGIES | 11046F |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |