MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2016-06-20 for UNKNOWN STERNALOCK BLUE SCREWS N/A UNKNOWN SL BLU SCREWS manufactured by Biomet Microfixation.
[47722200]
The warnings in the package insert state this type of event can occur. The user facility is foreign; therefore, a facility medwatch report will not be available. Because the lot number is unknown, the device history records could not be pulled and reviewed. Current information is insufficient to permit a valid conclusion about the cause of this event. If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent. This is report 2 of 2 for the same event. Report 1 of 2 is reported on mfr #0001032347-2016-00302.
Patient Sequence No: 1, Text Type: N, H10
[47722201]
It is reported that a revision surgery is planned to remove a broken sternalock blue plate and corresponding screw. The plate and screw currently remain in the patient's body.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2016-00303 |
| MDR Report Key | 5735393 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2016-06-20 |
| Date of Report | 2016-05-25 |
| Date Mfgr Received | 2016-05-25 |
| Date Added to Maude | 2016-06-20 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. MICHELLE COLE |
| Manufacturer Street | 1520 TRADEPORT DRIVE |
| Manufacturer City | JACKSONVILLE FL 32218 |
| Manufacturer Country | US |
| Manufacturer Postal | 32218 |
| Manufacturer Phone | 9047414400 |
| Manufacturer G1 | BIOMET MICROFIXATION |
| Manufacturer Street | 1520 TRADEPORT DRIVE |
| Manufacturer City | JACKSONVILLE FL 32218 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32218 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN STERNALOCK BLUE SCREWS |
| Generic Name | BONE SCREW |
| Product Code | HWD |
| Date Received | 2016-06-20 |
| Model Number | N/A |
| Catalog Number | UNKNOWN SL BLU SCREWS |
| Lot Number | UNKNOWN |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET MICROFIXATION |
| Manufacturer Address | 1520 TRADEPORT DRIVE JACKSONVILLE FL 32218 US 32218 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2016-06-20 |