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 2020-02-13 for TMJ SYSTEM RIGHT NARROW MANDIBULAR COMPONENT N/A 01-6545 manufactured by Biomet Microfixation.
[179252051]
(b)(4). The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. The device will not be returned for analysis; 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: 0001032347-2020-00104, 0001032347-2020-00105, 0001032347-2020-00106. Concomitant medical products: tmj system right narrow mandibular component, part# 01-6545, lot# 236980a; tmj system right fossa component, small, part# 24-6562, lot# 390170b; 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.
Patient Sequence No: 1, Text Type: N, H10
[179252052]
It was reported that the patient underwent a revision of temporomandibular implants on the right side due to heterotopic bone growth. Leading up to the revision, the patient complained of increased pain. During the revision, excess bone growth was removed around the joint and the fossa component was replaced. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2020-00103 |
| MDR Report Key | 9706098 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-02-13 |
| Date of Report | 2020-02-13 |
| Date of Event | 2019-10-24 |
| Date Mfgr Received | 2020-01-14 |
| Device Manufacturer Date | 2010-05-01 |
| Date Added to Maude | 2020-02-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 NARROW MANDIBULAR COMPONENT |
| Generic Name | JOINT, TEMPOROMANDIBULAR, IMPLANT |
| Product Code | LZD |
| Date Received | 2020-02-13 |
| Model Number | N/A |
| Catalog Number | 01-6545 |
| Lot Number | 236980A |
| 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 | 2020-02-13 |