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

Catalog Number	915-2101
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	12/23/2021
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: l-plt lt reg 2.0 lactosorb sys: cat# 915-2102; lot# 308570.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: 0001032347-2021-00583, 0001032347-2021-00584, 0001032347-2021-00585, 0001032347-2021-00586, 0001032347-2021-00587, 0001032347-2021-00588, 0001032347-2021-00589, 0001032347-2021-00590, 0001032347-2021-00591.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Event or Problem 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.
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 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 or Problem Description
No further event information is available at the time of this report.

• Brand Name: L-PLT RT REG 2.0 LACTOSORB SYS
• Common Device Name: 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: 13013741
• Report Number: 0001032347-2021-00582
• Device Sequence Number: 1727380
• Product Code: HRS
• UDI-Device Identifier: 00841036054397
• UDI-Public: (01)00841036054397(17)251102(10)181330
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K955729
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/28/2022

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: 11/02/2025
• Device Catalogue Number: 915-2101
• Device Lot Number: 181330
• 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: 12/06/2021
• Supplement Date Received by Manufacturer: 01/03/2022; 04/19/2022
• Initial Report FDA Received Date: 12/15/2021
• Supplement Report FDA Received Date: 01/05/2022; 04/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2020
• 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: Hospitalization; Other; Required Intervention
• Patient Sex: Unknown