MAUDE Adverse Event Report: BIOMET MICROFIXATION 50 MM LEFT NARROW MANDIBLE; MANDIBLE 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

(b)(4).Review of the device history records show that the lot was released with no recorded anomaly or deviation.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 1 of 6 for the same event.Reports 2 through 6 are reported on mfr #0001032347-2016-00269 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.

• Brand Name: 50 MM LEFT NARROW MANDIBLE
• Type of Device: MANDIBLE 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: 5695406
• MDR Text Key: 46432081
• Report Number: 0001032347-2016-00268
• 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
• 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: 02/12/2020
• Device Model Number: N/A
• Device Catalogue Number: 01-6551
• Device Lot Number: 584460C
• 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
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2015
• 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