MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-06-04 for PIN TO ROD COUPLING HOFFMANN II COMPACT 5/3-4MM 49401020 manufactured by Stryker Osteosynthesis-selzach.
[15023351]
It was reported that the sales rep received a phone call that the patient returned to the clinic for a follow up visit and the surgeons' assistant stated the surgeon replaced the broken pin to rod clamp with a new one.
Patient Sequence No: 1, Text Type: D, B5
[15463654]
Device will not be returned. If the device or additional information becomes available it will be reported on a supplemental report. (b)(4): device will not be returned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0008031020-2013-00173 |
| MDR Report Key | 3144228 |
| Report Source | 05 |
| Date Received | 2013-06-04 |
| Date of Report | 2013-05-13 |
| Date of Event | 2013-05-13 |
| Date Mfgr Received | 2013-05-13 |
| Date Added to Maude | 2013-06-04 |
| 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 | MR. ROSE MINCIELI |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | STRYKER OSTEOSYNTHESIS-SELZACH |
| Manufacturer Street | BOHNACKERWEG 1 POSTFACH |
| Manufacturer City | SELZACH 2545 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 2545 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PIN TO ROD COUPLING HOFFMANN II COMPACT 5/3-4MM |
| Generic Name | IMPLANT |
| Product Code | JEC |
| Date Received | 2013-06-04 |
| Catalog Number | 49401020 |
| Lot Number | X17615 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER OSTEOSYNTHESIS-SELZACH |
| Manufacturer Address | BOHNACKERWEG 1 POSTFACH SELZACH 2545 CH 2545 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-06-04 |