MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2011-02-23 for T-ADAPTOR CLAMP, BLUE MONOTUBE TRIAX 20MM 5150-4-070 manufactured by Stryker Osteosynthesis Selzach.
[1891141]
Head of materials administration, reported via our sales rep that the adaptor broke.
Patient Sequence No: 1, Text Type: D, B5
[8997746]
Additional info has been requested and if received, will be provided on a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8031020-2011-00048 |
| MDR Report Key | 2035236 |
| Report Source | 01,07 |
| Date Received | 2011-02-23 |
| Date of Report | 2011-02-07 |
| Date of Event | 2011-02-07 |
| Date Mfgr Received | 2011-02-07 |
| Date Added to Maude | 2011-06-15 |
| 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 | ROSE MINCIELI |
| Manufacturer Street | 325 CORPORATE DR |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | STRYKER OSTEOSYNTHESIS SELZACH |
| Manufacturer Street | BOHNACKERWEG 1 |
| Manufacturer City | SELZACH 2545 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 2545 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | T-ADAPTOR CLAMP, BLUE MONOTUBE TRIAX 20MM |
| Generic Name | IMPLANT |
| Product Code | JFC |
| Date Received | 2011-02-23 |
| Returned To Mfg | 2011-02-18 |
| Model Number | NA |
| Catalog Number | 5150-4-070 |
| Lot Number | J323736 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER OSTEOSYNTHESIS SELZACH |
| Manufacturer Address | SELZACH 2545 SZ 2545 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-02-23 |