MAUDE Adverse Event Report: BIOMET MICROFIXATION 2.0 LACTOSORB SYSTEM 2.0 X 7 MM LACTOSORB SCREW; PLATE, BONE

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Bone Fracture(s) (1870)

Event Date 05/12/2020

Event Type  Injury  

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 reports: 0001032347-2020-00254, 0001032347-2020-00255.Concomitant medical products: 2.0 lactosorb system l-shape plate - left extended, part# (b)(4), lot# 957040; 2.0 lactosorb system 2.0 x 7 mm lactosorb screw, part# (b)(4), lot# 369860.The user facility is foreign; therefore, a facility medwatch report will not be available.Report source: (b)(6).

Event 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.

Event Description

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

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# 915-2301, lot# 369860.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.The following fields were updated: b4 date of this report b5 describe event or problem g4 date received by manufacturer g7 type of report h2 follow up type h3 device evaluated by manufacturer h6 method code h6 results code h6 conclusions code h10 additional narratives/data.

• Brand Name: 2.0 LACTOSORB SYSTEM 2.0 X 7 MM LACTOSORB SCREW
• Type of Device: PLATE, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10115340
• MDR Text Key: 196738336
• Report Number: 0001032347-2020-00255
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 00841036055028
• UDI-Public: 00841036055028
• Combination Product (y/n): N
• PMA/PMN Number: K002083
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/04/2024
• Device Model Number: N/A
• Device Catalogue Number: 915-2301
• Device Lot Number: 369860
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 51 YR