MAUDE Adverse Event Report: BIOMET MICROFIXATION 1.5MM SYSTEM HIGH TORQUE (HT),SD,X-DR,SCR,5/PK; PLATE, BONE

Model Number N/A

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

Patient Problems Bruise/Contusion (1754); Necrosis (1971); Fluid Discharge (2686)

Event Date 08/26/2020

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).The device will not be returned for analysis as it was discarded; 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: 0001032347-2020-00404, 0001032347-2020-00405.Medical products: htr*pmi 2025734 left frontal temporal parietal implant, part# pm623210-b, lot# 986060.1.5mm system 6 hole extra long double y plate, part# 01-7114, lot# j416200.1.5mm system high torque (ht),sd,x-dr,scr,5/pk, part# 91-6104, lot# j416220.Unknown screws, part# ni, lot# ni.(b)(6).The user facility is foreign; therefore, a facility medwatch report will not be available.Foreign report source: (b)(6).

Event Description

It was reported a custom cranioplasty plate was removed due to necrosis two (2) months after implantation.A few days after surgery, a bruise was observed in the skin over the middle of the implant, and the bruise did not improve.Two (2) weeks prior to removal, the spot on the skin opened up with fluid escaping.No additional patient consequences have been reported.

Event Description

It was reported a custom cranioplasty plate was removed due to necrosis two (2) months after implantation.A few days after surgery, a bruise was observed in the skin over the middle of the implant, and the bruise did not improve.Two (2) weeks prior to removal, the spot on the skin opened up with fluid escaping.It has not been determined if the back-up implant will be used or if a new custom plate will be implanted in the coming months.No additional patient consequences have been reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2020-00404, 0001032347-2020-00405, 0001032347-2020-00406, 0001032347-2020-00430, 0001032347-2020-00431.D11 ¿ medical products htr*pmi 2025734 left frontal temporal parietal implant, part# pm623210-b, lot# 986060, 1.5mm system 6 hole extra long double y plate, part# 01-7114, lot# j416200, 1.5mm system high torque (ht),sd,x-dr,scr,5/pk, part# 91-6104, lot# j416220, 1.5mm system high torque (ht),sd,x-dr,screw 1.5mm x 5mm, part# 91-6105, lot# ni, 1.5mm system high torque (ht) cross-drive screw 1.8 x 5mm, part# 91-1805, lot# ni.

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.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 available at the time of this report.

• Brand Name: 1.5MM SYSTEM HIGH TORQUE (HT),SD,X-DR,SCR,5/PK
• Type of Device: PLATE, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10475095
• MDR Text Key: 205093888
• Report Number: 0001032347-2020-00406
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 00841036219505
• UDI-Public: 00841036219505
• Combination Product (y/n): N
• PMA/PMN Number: K121589
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• 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: 91-6104
• Device Lot Number: J416220
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention