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

Model Number N/A

Device Problem Output Problem (3005)

Patient Problem Wound Dehiscence (1154)

Event Date 12/27/2021

Event Type  Injury  

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 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.

Manufacturer Narrative

This report is being submitted to update additional information in section b4, b5, d4, g3, g6, h2, h4 and h10.

Event Description

No further event information is available at the time of this report.

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 Description

No further event information is available at the time of this report.

• Brand Name: LACTO SCR 2.0X7MM 2.0 SYS 2/PK
• 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: christina arnt ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 13401673
• MDR Text Key: 284804206
• Report Number: 0001032347-2022-00040
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 00888233025232
• UDI-Public: (01)00888233025232(17)251210(10)589700
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2022
• 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-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
• Date Manufacturer Received: 04/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2020
• 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
• Patient Outcome(s): Required Intervention