MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM CROSS-DRIVE FOSSA SCREW, 2.0 X 9 MM; BONE SCREW

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Ossification (1428); Debris, Bone Shedding (1803)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Medical product: biomet microfixation tmj system right standard mandibular component catalog #: 24-6545, lot #: 183570, biomet microfixation tmj system left standard mandibular component, small catalog #: 24-6546, lot #: 174120, biomet microfixation tmj system right fossa component, small catalog #: 24-6562, lot #: 216350, biomet microfixation tmj system left fossa component, small catalog #: 24-6563, lot #: 190720, biomet microfixation "2.4mm" system ht cross-drive screw, 2.7x10mm catalog #: 91-2710, lot #: ni, biomet microfixation "2.4mm" system ht cross-drive screw, 2.7x12mm catalog #: 91-2712, lot #: ni, biomet microfixation tmj system cross drive fossa screw, 2.0x7mm catalog #: 99-6577, lot #: ni.Therapy date: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation, it remains implanted.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 reports: 0001032347-2018-00754, 0001032347-2018-00755, 0001032347-2018-00756, 0001032347-2018-00757, 0001032347-2018-00758, 0001032347-2018-00759, and 0001032347-2018-00760.

Event Description

It was reported by the patient "her right implant is dislocated and has bone overgrowth and the left side has bone fragments".No additional patient consequences were reported.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.No product was returned, therefore no functional tests or inspections could be performed.No x-rays, scans, pictures, or physician's reports were provided.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

This follow-up report is being submitted to relay additional information.

• Brand Name: TMJ SYSTEM CROSS-DRIVE FOSSA SCREW, 2.0 X 9 MM
• Type of Device: BONE SCREW
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8052640
• MDR Text Key: 126996759
• Report Number: 0001032347-2018-00761
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• PMA/PMN Number: K910038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 99-6579
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1