MAUDE Adverse Event Report: BIOMET MICROFIXATION UNKNOWN LEFT MANDIBULAR COMPONENT; JOINT, TEMPOROMANDIBULAR, IMPLANT

Model Number N/A

Device Problem Positioning Failure (1158)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Concomitant medical products: medical product: unknown left fossa catalog#: ni lot#: ni; unknown screws catalog#: ni lot#: ni.Foreign: (b)(6).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: 0001032347-2021-00522 and 0001032347-2021-00524.

Event Description

It was reported the patient underwent a left tmj procedure on an unknown date.Subsequently, the patient was revised due to trauma with failed orif of mandible fracture and malocclusion with open bite right side and pathologic overjet, on an unknown date.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g3; g6; h1; h2; h3; h6; h10.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: UNKNOWN LEFT MANDIBULAR COMPONENT
• Type of Device: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: merrianne cassidy ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 12759248
• MDR Text Key: 283393593
• Report Number: 0001032347-2021-00523
• Device Sequence Number: 1
• Product Code: LZD
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN LEFT MANDIBLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/11/2021
• Initial Date FDA Received: 11/07/2021
• Supplement Dates Manufacturer Received: 11/22/2021
• Supplement Dates FDA Received: 12/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Required Intervention; Hospitalization