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 PERPOS PLS 9045-01 manufactured by Interventional Spine, Inc..
[16485418]
Root cause: due to the spinous process being in the way, the drill was moved off angle while drilling the hole. Excessive pressive placed on k-wire. 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
[16580250]
K-wire used in the surgery broke in the patient's sacrum. Broken piece remained in the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2032499-2011-00063 |
| MDR Report Key | 2045684 |
| Report Source | 05,07 |
| Date Received | 2011-02-28 |
| Date of Report | 2008-11-12 |
| Date of Event | 2008-10-24 |
| Date Mfgr Received | 2008-11-12 |
| 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 | PERPOS PLS |
| Product Code | MRW |
| Date Received | 2011-02-28 |
| Model Number | 9045-01 |
| Catalog Number | 9045-01 |
| Lot Number | 030708-A |
| Device Expiration Date | 2010-02-28 |
| 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 |