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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Purulent Discharge (1812); Swelling/ Edema (4577)
Date of Event	05/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint cmp (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, 0001032347-2021-00290, 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.Concomitant 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# 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.(b)(6).
Event or Problem 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.
Event or Problem Description
This follow-up report is being submitted to relay additional information.
Additional Manufacturer Narrative
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.

• Brand Name: 2.0 LACTOSORB SYSTEM 2.0 X 7 MM LACTOSORB SCREW
• Common Device Name: 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: 11872522
• Report Number: 0001032347-2021-00289
• Device Sequence Number: 2990246
• Product Code: JEY
• UDI-Device Identifier: 00841036055028
• UDI-Public: (01)00841036055028(17)240703(10)849260
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K002083
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 915-2301
• Device Lot Number: 849260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2021
• Supplement Date Received by Manufacturer: 01/21/2022
• Initial Report FDA Received Date: 05/24/2021
• Supplement Report FDA Received Date: 01/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 30 YR
• Patient Sex: Male