MAUDE Adverse Event Report: BIOMET MICROFIXATION TEMPOROMANDIBULAR JOINT SMALL LEFT FOSSA COMPONENT; FOSSA IMPLANT

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Fitting Problem (2183)

Patient Problems Facial Nerve Paralysis (1846); Nerve Damage (1979)

Event Type  Injury  

Manufacturer Narrative

The warnings in the package insert state this type of event can occur.The product was not returned for evaluation by the patient.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.This is report 2 of 6 for the same event.Reports 1, 3 through 6 are reported on mfr #0001032347-2016-00268, 0001032347-2016-00270 through 0001032347-2016-00273.

Event Description

It was reported that the implants she had placed on (b)(6) 2015 on her left side "were put in wrong" and had to be taken out.It was reported that a spacer is not implanted until a custom implant is ready for her.Upon follow-up, it was reported the implant was removed as a result of it becoming dislocated and shifting.This resulted in damage to the nerve which has left the patient paralyzed on the left side from the forehead through to the lower left jaw.There was no report of infection for this patient.It is reported that the fit was the reason for the revision.

Manufacturer Narrative

There were no x-rays or scans provided to confirm improper implantation or dislocation or patient anatomy.No additional information was provided about the circumstances that caused the implant to dislocate or the technique used during the implantation surgery.For the aforementioned reasons, the complaint cannot be verified.The most likely underlying cause of this complaint cannot be determined as the complaint is non-verifiable.During the investigation the device history record was reviewed for this part and lot, no non-conformances were identified.Unique identifier (udi) # (b)(4).Device received by mfr: was updated to reflect the date the investigation was completed.

• Brand Name: TEMPOROMANDIBULAR JOINT SMALL LEFT FOSSA COMPONENT
• Type of Device: FOSSA 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: michelle cole ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 5695418
• MDR Text Key: 46432869
• Report Number: 0001032347-2016-00269
• Device Sequence Number: 1
• Product Code: LZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP020016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 05/11/2016

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 Expiration Date: 12/03/2019
• Device Model Number: N/A
• Device Catalogue Number: 24-6563
• Device Lot Number: 578110A
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/11/2016
• Initial Date FDA Received: 06/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/31/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention