MAUDE Adverse Event Report: BIOMET MICROFIXATION LORENZ TITANIUM FRACTURE / RECONSTRUCTION PLATING SYSTEM; BONE, SCREW 2.7 X 8 MM HIGH TORQUE CROSS-DRIVE SCREW

Model Number N/A

Device Problem Noise, Audible (3273)

Patient Problems Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The warnings in the package insert state this type of event can occur.The product remains implanted in the patient and therefore will not be returned for an evaluation.Because the lot number is unknown, the device history records could not be pulled and reviewed.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 five of nine for the same event.Reports one through nine are reported on mfr #0001032347-2017-00532 through 0001032347-2017-00540.

Event Description

The patient stated he will have to have a revision surgery to implant custom joints because his left joint squeaks and he has limited opening.More information was requested but has yet to be received.

• Brand Name: LORENZ TITANIUM FRACTURE / RECONSTRUCTION PLATING SYSTEM
• Type of Device: BONE, SCREW 2.7 X 8 MM HIGH TORQUE CROSS-DRIVE SCREW
• 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: 6689309
• MDR Text Key: 79149028
• Report Number: 0001032347-2017-00536
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK001238
• 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: 07/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Device Unattended
• Device Model Number: N/A
• Device Catalogue Number: 91-2708
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention