MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-02-28 for PERPOS PLS SYSTEM; DRIVER 9045-02 manufactured by Interventional Spine, Inc..
[1859214]
One implant was implanted without incident. On the second implant, the driver was not advancing; it was observed that the driver would not engage with the screw. The third implant was implanted without incident.
Patient Sequence No: 1, Text Type: D, B5
[9083352]
Root cause. User error. Explanation: upon evaluation of the instrument that was returned, it was confirmed that the instrument was functional. The most probable cause was that the surgeon prematurely compressed the implant prior to implantation - this would have caused the event. It should be noted that initially ((b)(6) 2007), this event was determined to be not reportable. Upon re-review, it was decided that this should be reported. A visual and functional check was done on the returned instrument. The drive easily fit in to the driver portion of the screw. The implant was fully actuated. If an implant is partially actuated by accident, the driver will not mate with the screw.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2032499-2011-00015 |
| MDR Report Key | 2045715 |
| Report Source | 05 |
| Date Received | 2011-02-28 |
| Date of Report | 2007-11-28 |
| Date of Event | 2007-11-28 |
| Date Mfgr Received | 2007-11-28 |
| Device Manufacturer Date | 2006-06-02 |
| 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, STE 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 | PERPOS PLS SYSTEM; DRIVER |
| Generic Name | MRW; HXX |
| Product Code | MRW |
| Date Received | 2011-02-28 |
| Returned To Mfg | 2007-11-30 |
| Model Number | 9045-02 |
| Catalog Number | 9045-02 |
| Lot Number | 061907A |
| Device Availability | Y |
| 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 |