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 9045-02 manufactured by Interventional Spine, Inc..
[1857613]
The implant was compressed and the pull pin popped off. Compression was fine. Implant compressed all the way down. Used the driver to confirm the seating.
Patient Sequence No: 1, Text Type: D, B5
[9083346]
Root cause: (b)(4) pull pins were manufactured smaller than the dimensional requirements, causing them to thread into (b)(4) screws with minimal locking force. The supplier produced the (b)(4) pull pins using his own nominal targets without regard for tolerances based on the specified thread standard. As a corrective action, the pull pin supply was removed from the original mfr and moved to the same vendor who made the screws. In addition, all thread callouts are supplemented with specific dimensional tolerances. Initially, it was determined the event was not reportable. On a subsequent re-view, it was determined this event should have been reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2032499-2011-00030 |
| MDR Report Key | 2045582 |
| Report Source | 05,07 |
| Date Received | 2011-02-28 |
| Date of Report | 2009-07-22 |
| Date of Event | 2009-07-09 |
| Date Mfgr Received | 2009-07-22 |
| Device Manufacturer Date | 2009-06-01 |
| Date Added to Maude | 2012-02-13 |
| 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 PKWY., SUITE 160 |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9494720006 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 2032499-012511-001 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SCREW |
| Product Code | MRW |
| Date Received | 2011-02-28 |
| Model Number | 9045-02 |
| Catalog Number | 9045-02 |
| Lot Number | 060209-A |
| Device Expiration Date | 2011-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 |