FDA Adverse Event
Malfunction
Summary report: N
CENTERPIECE PLATE FIXATION SYSTEM
MDR report key: 5465771
·
Received February 29, 2016
Report
- Report Number
- 1030489-2016-00560
- Event Type
- Malfunction
- Date Received
- February 29, 2016
- Report Date
- February 4, 2016
- Manufacturer
- WARSAW ORTHOPEDICS
- Product Code
- NQW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(6). (B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, THE CATALOG # 853-465 AND 510K # (B)(4) OF 'LIKE DEVICES' WERE CLEARED IN THE UNITED STATES. NO APPLICABLE IMAGING FILMS AVAILABLE. HENCE IT IS DIFFICULT TO COME TO ANY CONCLUSION.
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT UNDERWENT LAMINOPLASTY ON AN UNKNOWN DATE. POST-OP, A SCREW WAS BACKED-OUT TO LAMINA. NO PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 124166 | CENTERPIECE PLATE FIXATION SYSTEM | ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL | NQW | WARSAW ORTHOPEDICS | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |