MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2011-08-11 for PERPOS FCD-2 ANCHOR AND STABILIZER 9062-00 manufactured by Interventional Spine, Inc..
[15408843]
Pt's first surgery was on (b)(6), 2010 and fcd-2 screws were implanted at l3-l4, l4-l5, and l5-s1. On (b)(6), 2011, dr. (b)(6) replaced a screw at the l3-l4 level having discovered that it fractured. He thinks that the fracture was due to an issue with how the implant was seated. Pt recovered satisfactorily.
Patient Sequence No: 1, Text Type: D, B5
[15717357]
Model# 9063-00, lot# 091409-b.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2032499-2011-00094 |
| MDR Report Key | 2219662 |
| Report Source | 05,07 |
| Date Received | 2011-08-11 |
| Date of Report | 2011-08-11 |
| Date of Event | 2011-07-26 |
| Date Mfgr Received | 2011-07-28 |
| Date Added to Maude | 2012-06-21 |
| 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 PARKWAY, 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 FCD-2 ANCHOR AND STABILIZER |
| Product Code | MRW |
| Date Received | 2011-08-11 |
| Model Number | 9062-00 |
| Lot Number | 091409-A |
| Device Expiration Date | 2011-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2011-08-11 |