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 9045-02 manufactured by Interventional Spine, Inc..
[1887082]
After implantation of a facet screw, the k-wire lifted the implant out of the bone.
Patient Sequence No: 1, Text Type: D, B5
[9174798]
Root cause: supplier machined the wires incorrectly. It should be noted that initially, this event was determined to be not reportable. Upon re-review, it was decided that this should be reported. Upon inspection of the returned k wire, it was noticed that the distal tip was larger than the non-threaded section. After cleaning, the wire was dimensionally inspected. The print calls out a dimension of. 062 +/-. 002"; the distal tip measured. 067" while the non threaded section met the print at. 062".
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2032499-2011-00013 |
| MDR Report Key | 2045714 |
| Report Source | 05 |
| Date Received | 2011-02-28 |
| Date of Report | 2007-07-12 |
| Date of Event | 2007-07-12 |
| Date Mfgr Received | 2007-07-12 |
| Device Manufacturer Date | 2007-06-19 |
| 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 SYSTEM |
| Generic Name | K WIRE |
| Product Code | MRW |
| Date Received | 2011-02-28 |
| Returned To Mfg | 2007-09-24 |
| Model Number | 9045-02 |
| Catalog Number | 9045-02 |
| Lot Number | 050907A |
| Device Expiration Date | 2009-04-30 |
| 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 |