MAUDE Adverse Event Report: BIOMET MICROFIXATION HTR*PMI INACIO DOS SANTOS SILVA LEFT FRONTAL SPHENOID PARIETAL TEMPORAL IMPLANT; HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT

Model Number N/A

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: foreign country - (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, it is implanted in the patient.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported during the surgery the implant did not fit the patient like it was fitting at the model.The surgeon was worried that the skull used to design the implant was bigger than the patient¿s actual skull.The design vendor reported after seeing the pre-op and post -op images together, the surgeon decided that she was satisfied with the results.No adverse events have been reported as a result of the malfunction.Attempts have been made and no further information has been provided.

Event Description

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

Manufacturer Narrative

The reported event was not confirmed.The design vendor conducted an investigation into the complaint; their results are as follows: a meeting was held on 08/09/2018 between the surgeon and the htr designer responsible for the design.The surgeon was concerned that the implant skull was designed on was bigger than the patient¿s actual skull.After reviewing the pre-op and post op images together, the surgeon decided that she was satisfied with the results and no further action needs to be taken.Device history record (dhr) was reviewed and no discrepancies were found.The complaint was not confirmed.There are no indications of manufacturing defects.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.

• Type of Device: HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 7835182
• MDR Text Key: 118886442
• Report Number: 0001032347-2018-00587
• Device Sequence Number: 1
• Product Code: KKY
• Combination Product (y/n): N
• PMA/PMN Number: PK924935
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: N/A
• Device Catalogue Number: PM620655
• Device Lot Number: 835180
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 13 YR