MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2013-05-20 for UNKNOWN_RECONSTRUCTIVE_PRODUCT UNK_REC manufactured by Stryker Orthopaedics-mahwah.
[3510029]
It was reported that the patient has a broken ulna implant according to the report the surgeon received. This patient has had chronic issues with these implants.
Patient Sequence No: 1, Text Type: D, B5
[3681699]
It was reported that the patient has a broken ulna implant according to the report the surgeon received. This patient has had chronic issues with these implants.
Patient Sequence No: 1, Text Type: D, B5
[10848050]
Catalogue number unknown at this time. Device description reported as an unknown ulna implant. An evaluation of the device cannot be performed as the device was not returned to the manufacturer due to hospital policy. Additional information pertaining to the device referenced in this report (including x-rays and medical records) has been requested. Should additional information become available, the evaluation summary will be submitted in a supplemental report. Device not returned to the manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[10980610]
The event was not confirmed as the reported device was not provided for evaluation. An x-ray was provided to a consulting clinician who rejected it for review as insufficient information was provided; however, the x-ray did confirm the fractured ulna. Device history review: could not be performed as no product identification was provided. Complaint history review: could not be performed as no product identification was provided. The exact root cause of the event could not be determined due to insufficient information provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0002249697-2013-01726 |
| MDR Report Key | 3120740 |
| Report Source | 00,05 |
| Date Received | 2013-05-20 |
| Date of Report | 2013-04-26 |
| Date of Event | 2013-04-26 |
| Date Mfgr Received | 2013-06-30 |
| Date Added to Maude | 2013-05-20 |
| 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. BELINDA DINES |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | STRYKER ORTHOPAEDICS-MAHWAH |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07430 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN_RECONSTRUCTIVE_PRODUCT |
| Generic Name | IMPLANT |
| Product Code | KXE |
| Date Received | 2013-05-20 |
| Catalog Number | UNK_REC |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ORTHOPAEDICS-MAHWAH |
| Manufacturer Address | 325 CORPORATE DRIVE MAHWAH NJ 07430 US 07430 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-05-20 |