MAUDE Adverse Event Report: BIOMET MICROFIXATION HTR-PMI 990476 RT FRT TEMP PAR; CRANIOPLASTY PLATE, NON-ALTERABLE

Catalog Number PM623817-A

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

Patient Problem Swelling/ Edema (4577)

Event Date 03/31/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: (b)(6).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.

Event Description

It was reported that a patient underwent an initial craniotomy.Subsequently, approximately (1) day post implantation due to a sudden brain swelling of unknown origin.The device was removed.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No further event information is available at the time of this report.

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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: HTR-PMI 990476 RT FRT TEMP PAR
• Type of Device: CRANIOPLASTY PLATE, NON-ALTERABLE
• 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: 12706355
• MDR Text Key: 278847353
• Report Number: 0001032347-2021-00496
• Device Sequence Number: 1
• Product Code: KKY
• UDI-Device Identifier: 00888233034976
• UDI-Public: (01)00888233034976(17)240204(10)026970
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K924935
• 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
• Report Date: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2024
• Device Catalogue Number: PM623817-A
• Device Lot Number: 026970
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2021
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 19 YR