MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2015-10-26 for ORTHOSORB 1 PIN 50X1.3MM KIT N/A 841070 manufactured by Biomet Trauma.
[29192657]
Current information is insufficient to permit a conclusion as to the cause of the event.
Patient Sequence No: 1, Text Type: N, H10
[29192658]
It was reported that patient underwent an unknown foot procedure on (b)(6) 2015. Subsequently, the patient was revised on (b)(6) 2015 due to pin migration. The pin was removed and another implant was not required. No further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
[31628652]
This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2015-04409 |
| MDR Report Key | 5176873 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2015-10-26 |
| Date of Report | 2015-10-26 |
| Date of Event | 2015-06-21 |
| Date Mfgr Received | 2015-10-26 |
| Device Manufacturer Date | 2014-03-13 |
| Date Added to Maude | 2015-10-26 |
| 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 | 3 |
| Manufacturer Contact | MS. MEGAN HAAS |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5743726700 |
| Manufacturer G1 | BIOMET TRAUMA |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORTHOSORB 1 PIN 50X1.3MM KIT |
| Generic Name | PIN, FIXATION |
| Product Code | OVZ |
| Date Received | 2015-10-26 |
| Model Number | N/A |
| Catalog Number | 841070 |
| Lot Number | 453619 |
| ID Number | N/A |
| Device Expiration Date | 2018-11-30 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET TRAUMA |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2015-10-26 |