MAUDE Adverse Event Report: BIOMET MICROFIXATION LORENZ RESORBABLE DISTRACTOR SYSTEM; LACTO SCR 2.0X7MM 2.0 SYS 2/PK

Model Number N/A

Device Problem Detachment Of Device Component (1104)

Patient Problem Swelling (2091)

Event Date 03/01/2014

Event Type  Injury  

Event Description

A revision surgery was reported due to the implant coming out of the bone.The customer reports the implant was exposed through the left nostril and the patient experienced swelling in the right nostril.

Manufacturer Narrative

The warning in the package insert states "bending, fracture, loosening, rubbing, and migration of the devices can occur as a result of excessive activity, trauma or load bearing" are possible adverse effects.Review of device history records show that lot released with no recorded anomaly or deviation.Review of device history records show that lot released with no recorded anomaly or deviation.The user facility is foreign; therefore, a facility medwatch report will not be available.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: LORENZ RESORBABLE DISTRACTOR SYSTEM
• Type of Device: LACTO SCR 2.0X7MM 2.0 SYS 2/PK
• 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: 3708378
• MDR Text Key: 21722255
• Report Number: 0001032347-2014-00092
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK002083
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/19/2014

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: 02/01/2018
• Device Model Number: N/A
• Device Catalogue Number: 915-2301
• Device Lot Number: 668490
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2014
• Initial Date FDA Received: 03/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 153