MAUDE Adverse Event Report: BIOMET MICROFIXATION LACTOSORB SYS L-PLT LT LRG 2.0; SCREW, FIXATION, BONE

Model Number N/A

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Impaired Healing (2378); Skin Tears (2516); Swelling/ Edema (4577)

Event Date 04/27/2022

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It is reported that the patient was revised due to plate exposure while suffering from sinusitis.The patient is not infected, and the size of the exposure was about 1.5 cm x 1.5 cm.The wound was left open to assist in treatment of the sinusitis.The patient is scheduled to have the exposed area closed at a later date.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This report is being submitted to update additional information in section b4, b5, d6, g3, g6, h2, h6 and h10.

Event Description

It has been further reported that the patient has not been revised of the implant to date.

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 records identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.This report is being submitted to update additional information in section b4, b5, d4, g3, g6, h2, h3, h4, h6 and h10.

• Brand Name: LACTOSORB SYS L-PLT LT LRG 2.0
• Type of Device: SCREW, 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 rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 14515788
• MDR Text Key: 292741946
• Report Number: 0001032347-2022-00169
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00841036054670
• UDI-Public: (01)00841036054670(17)260212(10)062300
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K992355
• 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,Followup
• Report Date: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2022
• 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: 915-2151
• Device Lot Number: 062300
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2021
• 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
• Patient Outcome(s): Required Intervention