MAUDE Adverse Event Report: BIOMET MICROFIXATION LACTO SCR 2.0X7MM 2.0 SYS 2/PK; PLATE, BONE

Model Number	N/A
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	12/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Medical products: item# 915-2301, lot# 894960, 2.0 lactosorb system 2.0 x 7 mm lactosorb screw; item# 915-2151, lot# 832450, 2.0 lactosorb system l-shape plate - left extended.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: 0001032347-2022-00003, 0001032347-2021-00002.
Event or Problem Description
It was reported patient underwent a revision procedure under local anesthesia approximately two months post-implantation due to drainage and plate exposure from the oral vestibule.
Additional Manufacturer Narrative
This report is being submitted to update additional information in section b4, b5, d4, g3, g6, h2, h4 and h10.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: LACTO SCR 2.0X7MM 2.0 SYS 2/PK
• 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: christina arnt ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 13401673
• Report Number: 0001032347-2022-00040
• Device Sequence Number: 4950796
• Product Code: JEY
• UDI-Device Identifier: 00888233025232
• UDI-Public: (01)00888233025232(17)251210(10)589700
• 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: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/21/2022

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: 12/10/2025
• Device Model Number: N/A
• Device Catalogue Number: 915-2301-EA
• Device Lot Number: 589700
• 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: 01/04/2022
• Supplement Date Received by Manufacturer: 03/30/2022; 04/14/2022
• Initial Report FDA Received Date: 01/31/2022
• Supplement Report FDA Received Date: 04/08/2022; 04/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown