MAUDE Adverse Event Report: BIOMET MICROFIXATION 2.0 LACTOSORB SYSTEM 2.0 X 7 MM LACTOSORB SCREW; PLATE, BONE

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, 0001032347-2021-00284, 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.Medical products 2.0 lactosorb system l-plate - left - regular, part# 915-2102, lot# 847100.2.0 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.Report source foreign: (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 patients 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.

Manufacturer Narrative

This report is being submitted to update additional information in section b4, b5, d1, d4, d9, g3, g6, h1, h2, h6 and h10.It was reported that approximately 10 months postop, the patient presented with signs of infection during the resorption stage of the implant.During the investigation process a review of the sterile certifications were reviewed and found to be conforming with no applicable deviations.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.As there are no indications of a product or process issues identified affecting implant safety or effectiveness, therefore implanted products are not identified as the source or contributing to the reported infection.Upon reassessment of the reported event based on additional information.This product did not cause or contribute to the reported event.This initial report submitted needs to be voided.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.

Event Description

This follow-up report is being submitted to relay additional information.

• Brand Name: 2.0 LACTOSORB SYSTEM 2.0 X 7 MM LACTOSORB SCREW
• Type of Device: PLATE, 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 Key: 11872679
• MDR Text Key: 254482377
• Report Number: 0001032347-2021-00300
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 00841036055028
• UDI-Public: (01)00841036055028(17)240731(10)850040
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K002083
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 915-2301
• Device Lot Number: 850040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2019
• 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
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Other
• Patient Age: 30 YR
• Patient Sex: Male