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 9024-00 manufactured by Interventional Spine, Inc..
[1858694]
The screw would not engage onto the drill and would not turn in the body. A new screw was used which did engage and turn and was implanted successfully.
Patient Sequence No: 1, Text Type: D, B5
[9084771]
Root cause: it appears the device was prematurely compressed. The clip was either removed too soon or the instrument was removed from the device and then placed back onto the device causing it to compress prematurely. Explanation: once the device is loaded onto the driver, the driver should not be removed from the device until the implant is in the desired location. This will prevent the device from compressing prematurely. This issue is not a result of device malfunction, but of user error. Initially it was determined the event was not reportable. On a subsequent re-review, it was determined this event should have been reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2032499-2011-00057 |
| MDR Report Key | 2045674 |
| Report Source | 05,07 |
| Date Received | 2011-02-28 |
| Date of Report | 2009-01-28 |
| Date of Event | 2009-01-21 |
| Date Mfgr Received | 2009-10-08 |
| 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 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 | SCREW |
| Product Code | MRW |
| Date Received | 2011-02-28 |
| Model Number | 9024-00 |
| Catalog Number | 9024-00 |
| Lot Number | 070308-A |
| Device Expiration Date | 2011-06-01 |
| 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 |