MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2011-02-28 for SCREW 6070 / 9024-00 9024-00 manufactured by Interventional Spine, Inc..
[1858687]
Two in one at the drill bit is "widened" / implant broke during operation.
Patient Sequence No: 1, Text Type: D, B5
[9084333]
Root cause: screw: inconclusive. No damage was observed and the part functioned properly when tested. Drill: ifu states to use this for one case only and then discard. Initially it was determined the event was not reportable. On a subsequent re-review, it was determined this event should have been reported. Device evaluation: screw - device was fully compressed. Device was mechanically tested and met specifications. Drill - drill was dissected to measure wall thickness. Wall thickness met specifications. Drill distal tip was fanned out and had microscopic cracks.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2032499-2011-00069 |
| MDR Report Key | 2045638 |
| Report Source | 05,07 |
| Date Received | 2011-02-28 |
| Date of Report | 2009-03-12 |
| Date of Event | 2009-02-25 |
| Date Mfgr Received | 2009-03-12 |
| Device Manufacturer Date | 2008-01-01 |
| Date Added to Maude | 2012-02-10 |
| 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 PKWY., 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 | SCREW |
| Product Code | MRW |
| Date Received | 2011-02-28 |
| Returned To Mfg | 2009-03-31 |
| Model Number | 6070 / 9024-00 |
| Catalog Number | 9024-00 |
| Lot Number | 062907A / 010408-A |
| Device Expiration Date | 2011-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERVENTIONAL SPINE, INC. |
| Manufacturer Address | IRVINE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-02-28 |