MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2012-05-02 for XIA DEFORMITY REDUCTION LONG ARM POLYAXIAL SCREW 6 03829645 manufactured by Stryker Spine Bordeaux.
[2722223]
Dr. (b)(6) reported to (b)(6): dr. (b)(4) (spine sales mgr) that the pt is a case of congenital spondylolisthesis. The dr has done a screw fixation and listhesis reduction with 4 screws. After the pt feels pain and radiculopathy is low back and his lower extremity. The dr asks for a control x-ray which shows 3 broken screws and an about to loose blocker.
Patient Sequence No: 1, Text Type: D, B5
[9851190]
Add'l info has been requested, and if made available, this will be reported as supplemental. Method, result and conclusion codes will be made available following an engineering eval.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9617544-2012-00177 |
| MDR Report Key | 2574066 |
| Report Source | 01,07 |
| Date Received | 2012-05-02 |
| Date of Report | 2012-04-05 |
| Date of Event | 2012-04-05 |
| Date Mfgr Received | 2012-04-05 |
| Date Added to Maude | 2012-05-16 |
| 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 Contact | SIOBHAN OMALLEY |
| Manufacturer Street | 2 PEARL COURT |
| Manufacturer City | ALLENDALE NJ 07401 |
| Manufacturer Country | US |
| Manufacturer Postal | 07401 |
| Manufacturer Phone | 2017608074 |
| Manufacturer G1 | STRYKER SPINE BORDEAUX |
| Manufacturer Street | ZONE INDUSTRIELLE DEMARTICOT |
| Manufacturer City | CESTAS 33610 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 33610 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XIA DEFORMITY REDUCTION LONG ARM POLYAXIAL SCREW 6 |
| Generic Name | IMPLANT |
| Product Code | NXB |
| Date Received | 2012-05-02 |
| Model Number | NA |
| Catalog Number | 03829645 |
| Lot Number | TBC |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER SPINE BORDEAUX |
| Manufacturer Address | CESTAS 33610 FR 33610 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2012-05-02 |