MAUDE Adverse Event Report: BIOMET MICROFIXATION 2.0 LACTOSORB SYSTEM L-SHAPE PLATE - LEFT EXTENDED; PLATE, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).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 report: 0001032347-2020-00255.Concomitant medical products: 2.0 lactosorb system l-shape plate - left extended, part# 915-2151, lot# 957040.2.0 lactosorb system 2.0 x 7 mm lactosorb screw, part# 915-2301, lot# 369860.The user facility is foreign; therefore, a facility medwatch report will not be available.Report source: foreign country: (b)(6).
Event or Problem Description
It was reported a re-operation was performed due to plate exposure five (5) months following implantation.The plate had been implanted on the maxilla at a zygomatic fracture during an open reduction and internal fixation procedure and five (5) months later the corner of the plate was exposed.No infection was reported to have occurred and the plate was removed in a revision.No additional patient consequences have been reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint is considered confirmed because a revision surgery was reported.The devices were not returned for investigation and no photos were provided.For these reasons, no functional testing or visual evaluations could be conducted.No x-rays, scans, photos, or physician's reports were provided.The dhr for this device was reviewed; no non-conformances were found.There are no indications of manufacturing defects.This is the only complaint regarding extrusion of the material through skin for this item# 915-2151, lot# 957040.The most likely underlying cause could not be determined.It is possible that the device was placed directly under the incision, near the skin surface.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
This follow-up report is being submitted to relay additional information.

• Brand Name: 2.0 LACTOSORB SYSTEM L-SHAPE PLATE - LEFT EXTENDED
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10115321
• Report Number: 0001032347-2020-00254
• Device Sequence Number: 1762873
• Product Code: HRS
• UDI-Device Identifier: 00841036054670
• UDI-Public: 00841036054670
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K992355
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/04/2024
• Device Model Number: N/A
• Device Catalogue Number: 915-2151
• Device Lot Number: 957040
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/25/2020
• Supplement Date Received by Manufacturer: 11/13/2020
• Initial Report FDA Received Date: 06/03/2020
• Supplement Report FDA Received Date: 11/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 51 YR