MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-01-15 for TMJ SYSTEM RIGHT STANDARD MANDIBULAR COMPONENT N/A 24-6555 manufactured by Biomet Microfixation.
[175108787]
(b)(4). The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. It is unknown at this time if the device will be returned for evaluation; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2020-00069, 0001032347-2020-00070, 0001032347-2020-00071, 0001032347-2020-00072, 0001032347-2020-00073, 0001032347-2020-00074. Concomitant medical products: tmj system right standard mandibular component, part# 24-6555, lot# 842720b; tmj system left standard mandibular component, part# 24-6556, lot# 793820b; tmj system right fossa component, small, part# 24-6562, lot# 861210a; tmj system left fossa component, small, part# 24-6563, lot# 864820a; 2. 4mm system high torque (ht) cross-drive screw, part# 91-2710, lot# unk; tmj system cross drive fossa screw, part# 99-6577, lot# unk; tmj system cross drive fossa screw, part# 99-6579, lot# unk.
Patient Sequence No: 1, Text Type: N, H10
[175108788]
It was reported the patient underwent a bilateral revision of temporomandibular joint prostheses due to an unknown reason. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2020-00068 |
| MDR Report Key | 9592384 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-01-15 |
| Date of Report | 2020-01-15 |
| Date Mfgr Received | 2019-12-20 |
| Device Manufacturer Date | 2018-09-10 |
| Date Added to Maude | 2020-01-15 |
| 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. JENNIFER DELANEY |
| 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 | TMJ SYSTEM RIGHT STANDARD MANDIBULAR COMPONENT |
| Generic Name | JOINT, TEMPOROMANDIBULAR, IMPLANT |
| Product Code | LZD |
| Date Received | 2020-01-15 |
| Model Number | N/A |
| Catalog Number | 24-6555 |
| Lot Number | 842720B |
| 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 | 2020-01-15 |