MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2007-04-17 for RADIUS LOCKING CAPS 486610000 manufactured by Stryker Spine Bordeaux.
[733309]
It was reported that, "t4-pelvis hybrid construct (90d+radius). Top cap of construct t4 poped off. Seen on post op visit. "
Patient Sequence No: 1, Text Type: D, B5
[8117525]
No product is available for evaluation. Additional information has been requested and if received, will be supplied on a supplemental.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9617544-2007-00019 |
| MDR Report Key | 940429 |
| Report Source | 07 |
| Date Received | 2007-04-17 |
| Date of Report | 2007-03-23 |
| Date of Event | 2007-03-23 |
| Date Mfgr Received | 2007-03-23 |
| Date Added to Maude | 2007-11-13 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | MICHELLE KLEIN |
| Manufacturer Street | 2 PEARL COURT |
| Manufacturer City | ALLENALE NJ 07401 |
| Manufacturer Country | US |
| Manufacturer Postal | 07401 |
| Manufacturer Phone | 2017608256 |
| Manufacturer G1 | STRYKER SPINE BORDEAUX |
| Manufacturer Street | ZONE INDUSTRIELLE DE MARTICOT |
| Manufacturer City | CESTAS 33610 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 33610 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RADIUS LOCKING CAPS |
| Generic Name | IMPLANT |
| Product Code | JDT |
| Date Received | 2007-04-17 |
| Model Number | NA |
| Catalog Number | 486610000 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 912571 |
| Manufacturer | STRYKER SPINE BORDEAUX |
| Manufacturer Address | * CESTAS FR 33610 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-04-17 |