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 SYSTEM 9045-02 manufactured by Interventional Spine, Inc..
[21409889]
Pull pin would not unthread out of the implant. The surgeon was able to place the first implant and get the pull pin off, on the second one they had to use a pair of needle nose pliers to get the pull pin off. The patient was fine and the pull pin was thrown away.
Patient Sequence No: 1, Text Type: D, B5
[21482033]
Root cause: root cause not determined. Implant was not returned. No evidence of a particular trend or distinction. Explanation: lot history record pn 9045-02, ln 010410-d was pulled and reviewed. No nonconformances were noted. 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 | 2032499-2011-00045 |
| MDR Report Key | 2045623 |
| Report Source | 05,07 |
| Date Received | 2011-02-28 |
| Date of Report | 2010-03-12 |
| Date of Event | 2010-03-11 |
| Date Mfgr Received | 2010-03-12 |
| Device Manufacturer Date | 2010-01-01 |
| 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 |
| Removal Correction Number | 2032499-012511-001 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERPOS PLS SYSTEM |
| Product Code | MRW |
| Date Received | 2011-02-28 |
| Model Number | 9045-02 |
| Catalog Number | 9045-02 |
| Lot Number | 010410-D |
| Device Expiration Date | 2011-12-31 |
| 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 |