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 9045-01 manufactured by Interventional Spine, Inc..
[19911035]
Physician opened up a single screw kit for use; however, according to the physician the plastic sleeve was off the screw and the screw was slightly compressed. Physician used another kit instead.
Patient Sequence No: 1, Text Type: D, B5
[19937670]
Root cause: the investigation was inconclusive. Most probable root cause was that burrs on the clip prevented the clip to seat flush with the ratchet teeth, allowed the implant to slightly compress. 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: returned device was visually inspected. Plastic clip on device was slightly askew. This clip prevents the implant from compressing during shipping.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2032499-2011-00067 |
| MDR Report Key | 2045693 |
| Report Source | 05,07 |
| Date Received | 2011-02-28 |
| Date of Report | 2009-02-25 |
| Date Mfgr Received | 2009-02-25 |
| 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 | 2009-04-10 |
| Model Number | 9045-01 |
| Catalog Number | 9045-01 |
| Lot Number | 070108-B |
| Device Expiration Date | 2010-06-30 |
| 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 |