MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-11-07 for 4.5MM BONE-LOK PLS IMPLANT LSW-45-3040 manufactured by Interventional Spine, Inc..
[16924698]
Found that screw broke after 6 weeks.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2032499-2011-00097 |
| MDR Report Key | 2360820 |
| Report Source | 05 |
| Date Received | 2011-11-07 |
| Date of Report | 2011-11-02 |
| Date of Event | 2011-10-26 |
| Date Mfgr Received | 2011-11-02 |
| Device Manufacturer Date | 2009-03-01 |
| Date Added to Maude | 2012-07-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 13700 ALTON PARKWAY SUITE 160 |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9494720006 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 4.5MM BONE-LOK PLS IMPLANT |
| Product Code | MRW |
| Date Received | 2011-11-07 |
| Model Number | LSW-45-3040 |
| Lot Number | 031909-A/010410-A |
| Device Expiration Date | 2012-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERVENTIONAL SPINE, INC. |
| Manufacturer Address | IRVINE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-07 |