MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2015-12-08 for ORTHOSORB LS 1.3MM 3 PIN KIT N/A 110010742 manufactured by Biomet Trauma.
[32895997]
The product identification necessary to review manufacturing history was not provided. Current information is insufficient to permit a conclusion as to the cause of the event. There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 3 states,? Bending, fracture, loosening, rubbing and migration of the devices can occur as a result of excessive activity, trauma or load bearing.?
Patient Sequence No: 1, Text Type: N, H10
[32895998]
It was reported that patient underwent an unknown procedure on an unknown date. Subsequently, a revision procedure has been indicated due to fracturing pins; however, no revision has been reported at this time. No further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2015-04912 |
| MDR Report Key | 5273572 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2015-12-08 |
| Date of Report | 2015-11-19 |
| Date Mfgr Received | 2015-11-19 |
| Date Added to Maude | 2015-12-08 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 LS 1.3MM 3 PIN KIT |
| Generic Name | PIN, FIXATION |
| Product Code | OVZ |
| Date Received | 2015-12-08 |
| Model Number | N/A |
| Catalog Number | 110010742 |
| Lot Number | UNKNOWN |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | N |
| 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 | 2015-12-08 |