MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2018-08-07 for "2.4MM" LOCKING RECON SYSTEM RIGHT ADD-ON CONDYLE 1 CONDYLE 3 SCREWS N/A 01-2692 manufactured by Biomet Microfixation.
[116299872]
(b)(4). Medical product: biomet microfixation total mandibular system add-on condyle plate, catalog #: 24-4545, lot #: ni, unknown screws, catalog #: ni, lot #: ni. Therapy date: unknown. Report source: foreign country - (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated report: 0001032347-2018-00465.
Patient Sequence No: 1, Text Type: N, H10
[116299873]
It was reported a revision was performed due to a plate fracture. No additional patient consequences were reported. Attempts have been made and no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2018-00464 |
| MDR Report Key | 7758945 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-08-07 |
| Date of Report | 2018-12-20 |
| Date of Event | 2018-06-18 |
| Date Mfgr Received | 2018-12-07 |
| Date Added to Maude | 2018-08-07 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | "2.4MM" LOCKING RECON SYSTEM RIGHT ADD-ON CONDYLE 1 CONDYLE 3 SCREWS |
| Generic Name | ADD-ON CONDYLE |
| Product Code | NEI |
| Date Received | 2018-08-07 |
| Model Number | N/A |
| Catalog Number | 01-2692 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2018-08-07 |