FDA Adverse Event
Malfunction
Summary report: N
LANX CERVICAL SA INTERVERTEBRAL BODY FUSION SYS
MDR report key: 3162461
·
Received June 6, 2013
Report
- Report Number
- 3004485144-2013-00014
- Event Type
- Malfunction
- Date Received
- June 6, 2013
- Date of Event
- May 8, 2013
- Report Date
- May 8, 2013
- Manufacturer
- LANX, INC
- Product Code
- OVE
- PMA / PMN Number
- 112388
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
REVIEW OF DHR DID NOT IDENTIFY ANY MFG ISSUES THAT WOULD HAVE CONTRIBUTED TO THE EVENT. REVIEW OF THE PRODUCT LABELING IDENTIFIED ADEQUATE INSTRUCTIONS FOR USE.
Description of Event or Problem · 1
THE DRIVE FEATURES ON TWO SCREW DRIVERS STRIPPED DURING A SURGERY AND EXTENDED THE SURGERY TIME BY 45 MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 250268 | LANX CERVICAL SA INTERVERTEBRAL BODY FUSION SYS | INTERVERTEBRAL BODY FUSION DEVICE | OVE | LANX, INC | 8430-0X01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | (B)(4) SCREWS |