MAUDE Adverse Event Report: BIOMET MICROFIXATION L-PLT LT REG 2.0 LACTOSORB SYS; CRANIOFACIAL FIXATION PLATE, BIOABSORBABLE

Catalog Number 915-2102

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Swelling/ Edema (4577)

Event Date 12/23/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: l-plt rt reg 2.0 lactosorb sys, cat# 915-2101, lot# 181330; qty: 8 of lacto scr 2.0x7mm 2.0 sys 2/pk, cat# 915-2301, lot# 480430.Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2021-00582, 0001032347-2021-00584, 0001032347-2021-00585 0001032347-2021-00586, 0001032347-2021-00587, 0001032347-2021-00588, 0001032347-2021-00589, 0001032347-2021-00590, 0001032347-2021-00591.

Event Description

It was reported that a patient experienced swelling approximately 8 months after a piriform aperture with lactosorb for maxillary osteotomy.The patient has indicated for a revision, although it has yet to occur.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

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

Event Description

It was reported that a patient underwent a revision procedure approximately 8 months after a piriform aperture with lactosorb for maxillary osteotomy due to swelling.Attempts have been made and additional information on the reported event is unavailable at this time.

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.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: L-PLT LT REG 2.0 LACTOSORB SYS
• Type of Device: CRANIOFACIAL FIXATION PLATE, BIOABSORBABLE
• 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: 13013637
• MDR Text Key: 285009766
• Report Number: 0001032347-2021-00583
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00841036054410
• UDI-Public: (01)00841036054410(17)251109(10)308570
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K955729
• 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: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 915-2102
• Device Lot Number: 308570
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Other; Required Intervention