MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-12-03 for CONNECTING ROD HOFFMANN II ? 8 X 150MM 50298815 manufactured by Stryker Trauma Selzach.
[4008782]
On (b)(6) 2013, the patient underwent the surgery with hoffmann 2 and hoffmann 3 to the ankle joint fixation. After surgery, the patient underwent an exam by mri. According to the patient, sense of discomfort was felt during exam of mri. Therefore the surgeon is monitoring the patient.
Patient Sequence No: 1, Text Type: D, B5
[11331696]
Device will not be returned. If additional information becomes available it will be provided on a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0008031020-2013-00437 |
| MDR Report Key | 3496773 |
| Report Source | 05 |
| Date Received | 2013-12-03 |
| Date of Report | 2013-11-06 |
| Date of Event | 2013-11-06 |
| Date Mfgr Received | 2013-11-06 |
| Date Added to Maude | 2014-03-03 |
| 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 TRAUMA 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 | CONNECTING ROD HOFFMANN II ? 8 X 150MM |
| Generic Name | SMOOTH OR THREADED METALLIC BONE FIXATION FASTENER |
| Product Code | JEC |
| Date Received | 2013-12-03 |
| Catalog Number | 50298815 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER TRAUMA SELZACH |
| Manufacturer Address | BOHNACKERWEG 1 POSTFACH SELZACH 2545 CH 2545 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-12-03 |