MAUDE Adverse Event Report: BIOMET MICROFIXATION HTR-PMI RT FRT SP PAR T

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 12/20/2013

Event Type  Injury  

Event Description

A delay in surgery was reported due to the custom implant being modified.

Manufacturer Narrative

The warnings in the package insert state this type of event can occur.Without a product return, no product evaluation is able to be conducted.The product remains implanted in the patient.The ifu indicates that these custom devices are manufactured and designed to fit the patient at the time of the ct scan and may require cosmetic modifications for optimal fit to the patient's anatomy.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.

• Brand Name: HTR-PMI RT FRT SP PAR T
• Type of Device: HTR
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: amanda sisk ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 3576700
• MDR Text Key: 4034152
• Report Number: 0001032347-2014-00009
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK953385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/20/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2018
• Device Model Number: N/A
• Device Catalogue Number: PM614384
• Device Lot Number: 489870
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2013
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1