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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET MICROFIXATION 2.0 LACTOSORB SYSTEM L-PLATE - LEFT - REGULAR PLATE, FIXATION, BONE

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BIOMET MICROFIXATION 2.0 LACTOSORB SYSTEM L-PLATE - LEFT - REGULAR PLATE, FIXATION, BONE Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Purulent Discharge (1812); Swelling/ Edema (4577)
Event Date 05/06/2021
Event Type  Injury  
Manufacturer Narrative

Zimmer biomet complaint (b)(4). The device will not be returned for analysis; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2021-00283, 0001032347-2021-00285, 0001032347-2021-00286, 0001032347-2021-00287, 0001032347-2021-00288, 0001032347-2021-00289, 0001032347-2021-00290, 0001032347-2021-00291, 0001032347-2021-00292, 0001032347-2021-00293, 0001032347-2021-00294, 0001032347-2021-00295, 0001032347-2021-00296, 0001032347-2021-00297, 0001032347-2021-00298, 0001032347-2021-00299, 0001032347-2021-00300. Medical products: 2. 0 lactosorb system l-plate - left - regular, part# 915-2102, lot# 847100. 2. 0 lactosorb system 2. 0 x 7 mm lactosorb screw, part# 915-2301, lot# 849260. 2. 0 lactosorb system 2. 0 x 7 mm lactosorb screw, part# 915-2301, lot# 849260. 2. 0 lactosorb system 2. 0 x 7 mm lactosorb screw, part# 915-2301, lot# 849260. 2. 0 lactosorb system 2. 0 x 7 mm lactosorb screw, part# 915-2301, lot# 849260. 2. 0 lactosorb system 2. 0 x 7 mm lactosorb screw, part# 915-2301, lot# 849260. 2. 0 lactosorb system 2. 0 x 7 mm lactosorb screw, part# 915-2301, lot# 849260. 2. 0 lactosorb system 2. 0 x 7 mm lactosorb screw, part# 915-2301, lot# 849260. 2. 0 lactosorb system 2. 0 x 7 mm lactosorb screw, part# 915-2301, lot# 849260. 2. 0 lactosorb system 2. 0 x 7 mm lactosorb screw, part# 915-2301, lot# 849280. 2. 0 lactosorb system 2. 0 x 7 mm lactosorb screw, part# 915-2301, lot# 849280. 2. 0 lactosorb system 2. 0 x 7 mm lactosorb screw, part# 915-2301, lot# 849280. 2. 0 lactosorb system 2. 0 x 7 mm lactosorb screw, part# 915-2301, lot# 849280. 2. 0 lactosorb system 2. 0 x 7 mm lactosorb screw, part# 915-2301, lot# 850040. 2. 0 lactosorb system 2. 0 x 7 mm lactosorb screw, part# 915-2301, lot# 850040. 2. 0 lactosorb system 2. 0 x 7 mm lactosorb screw, part# 915-2301, lot# 850040. 2. 0 lactosorb system 2. 0 x 7 mm lactosorb screw, part# 915-2301, lot# 850040. Report source ¿ (b)(6).

 
Event Description

It was reported the patient experienced an infection nine (9) months following fixation with resorbable implants after a maxillary osteotomy of the upper left jaw. During the resorption stage, the patient¿s gums were swollen and pus was excreted. The surgeon is monitoring the patient and no revision is planned. It was reported that no further information is available.

 
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Brand Name2.0 LACTOSORB SYSTEM L-PLATE - LEFT - REGULAR
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
BIOMET MICROFIXATION
1520 tradeport drive
jacksonville FL 32218
Manufacturer (Section G)
BIOMET MICROFIXATION
1520 tradeport drive
jacksonville FL 32218
Manufacturer Contact
jennifer delaney
1520 tradeport drive
jacksonville, FL 32218
9047414400
MDR Report Key11872445
MDR Text Key252368885
Report Number0001032347-2021-00284
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK955729
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,HEALTH PR
Reporter Occupation
Type of Report Initial
Report Date 05/24/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/24/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number915-2102
Device LOT Number847100
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/10/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/03/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 05/24/2021 Patient Sequence Number: 1
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