MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-03 for TRAUMAONE SYSTEM 2.0X7MM SELF-DRILLING IMF SCREW N/A 91-5607 manufactured by Biomet Microfixation.
[174885047]
Zimmer biomet complaint (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 as it remains implanted; 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: 0001032347-2020-00014, 0001032347-2020-00015, 0001032347-2020-00016, 0001032347-2020-00018. Medical products: tmj system right narrow mandibular component, part# 01-6550, lot# 541410c, tmj system right fossa component, small, part# 24-6562, lot# 561150a, 2. 4mm system high torque (ht) cross-drive screw, part# 91-2710, lot# unk, traumaone system 2. 0x7mm self-drilling imf screw, part# 91-5607, lot# unk, tmj system cross drive fossa screw, part# 99-6577, lot# unk. Occupation: patient.
Patient Sequence No: 1, Text Type: N, H10
[174885048]
It was reported the patient may undergo a revision of temporomandibular joint implants on the right side at a later unspecified date due to an unknown reason. No additional patient consequences have been reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2020-00017 |
| MDR Report Key | 9546679 |
| Report Source | CONSUMER |
| Date Received | 2020-01-03 |
| Date of Report | 2020-03-12 |
| Date Mfgr Received | 2020-02-20 |
| Date Added to Maude | 2020-01-03 |
| 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 | TRAUMAONE SYSTEM 2.0X7MM SELF-DRILLING IMF SCREW |
| Generic Name | SCREW, FIXATION, INTRAOSSEOUS |
| Product Code | DZL |
| Date Received | 2020-01-03 |
| Model Number | N/A |
| Catalog Number | 91-5607 |
| Lot Number | N/A |
| 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. Required No Informationntervention | 2020-01-03 |