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..
[1887079]
Difficult to screw the device. Implantation with a perpos system as usual. While turning the screw he realized that this one was really difficult to screw. Under x-ray view, one could see that the screw just fitted somewhat and that the screw was shortened as well. That means the out part had already crimped with the screw. A further turning neither forward or backwards was possible. The pull-pin was too long. Even after removing the pull-pin the screw could only be unscrewed and replaced with another system, which could be placed very well.
Patient Sequence No: 1, Text Type: D, B5
[9174795]
Root cause: premature compression; 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: additional training for the customer to: the clip cannot be removed too soon. To keep the device and driver engaged until the desired depth. 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 implant was visually inspected. Device did not reveal anything that would lead to premature decompression of the device. The pull pin was slightly bent and scored on the (b)(4) which was likely caused during pin removal.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2032499-2011-00062 |
| MDR Report Key | 2045699 |
| Report Source | 05,07 |
| Date Received | 2011-02-28 |
| Date of Report | 2008-10-10 |
| Date of Event | 2008-09-23 |
| Date Mfgr Received | 2008-10-10 |
| Device Manufacturer Date | 2008-03-01 |
| 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 |
| Model Number | 9024-00 |
| Catalog Number | 9024-00 |
| Lot Number | 030508-A |
| Device Expiration Date | 2011-02-28 |
| 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 |