MAUDE Adverse Event Report: BIOMET MICROFIXATION PECTUS SYSTEM 13" PECTUS SUPPORT BAR; PLATE, FIXATION, BONE

Model Number N/A

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.It is unknown at this time if the device will be returned for evaluation.Attempts have been made but no further information is available at this time.

Event Description

It was reported that a patient was presenting with metal allergies following the implantation of a pectus bar.Attempts have been made but no further information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint was opened because a metal allergy on behalf of the surgeon.The lorenz pectus support bar 13in (part# 01-3713, lot# unk) was not returned for investigation.Physician confirmed a metal patch test was done and came back negative.The patient's rash was resolved with prescribed oral and topical medication and has not recurred since; therefore the complaint is unconfirmed and the most likely underlying cause could not be determined.There are no indications of manufacturing defects.For this part (01-3713) and the previous one year (from the notification date), there was a complaint rate of (b)(4) which is no greater than the occurrence listed in the application fmea.There is no indication of manufacturing defects and there are no updates to the risk documents needed.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

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

• Brand Name: PECTUS SYSTEM 13" PECTUS SUPPORT BAR
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9175319
• MDR Text Key: 161986924
• Report Number: 0001032347-2019-00439
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00841036011031
• UDI-Public: 00841036011031
• Combination Product (y/n): N
• PMA/PMN Number: K972420
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2019
• 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: 01-3713
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention