MAUDE Adverse Event Report: BIOMET MICROFIXATION LORENZ LACTOSORB LARYNGOTRACHEAL RECONSTRUCTION IMPLANTS; ABSORBABLY SYNTHETIC POLYMER, 1.5 X 4 MM DIRECT-DRIVE LACTOSORB SCREW

Model Number N/A

Device Problem Fracture (1260)

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

Event Date 02/22/2017

Event Type  Injury  

Manufacturer Narrative

Review of the device history records shows the lot was released with no recorded anomaly or deviation.The warnings in the package insert state this type of event can occur.The user facility is foreign; therefore a facility medwatch report will not be available.Without a product return, no product evaluation is able to be conducted.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.

Event Description

It was reported three screws broke during surgery.The procedure was completed with additional screws of the same item number.More information was requested but was not provided by the hospital.

• Brand Name: LORENZ LACTOSORB LARYNGOTRACHEAL RECONSTRUCTION IMPLANTS
• Type of Device: ABSORBABLY SYNTHETIC POLYMER, 1.5 X 4 MM DIRECT-DRIVE LACTOSORB 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: 6525390
• MDR Text Key: 73800141
• Report Number: 0001032347-2017-00324
• Device Sequence Number: 1
• Product Code: NHB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: PK012409
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2019
• Device Model Number: N/A
• Device Catalogue Number: 915-2215
• Device Lot Number: 700710
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2014
• 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): Required Intervention
• Patient Age: 6 YR