MAUDE Adverse Event Report: BIOMET MICROFIXATION UNKNOWN TITANIUM PECTUS BAR; CUSTOM PECTUS BAR

Model Number N/A

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

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.The product remains implanted in the patient, but a revision may occur at a later unspecified date at which time the device may be returned for testing.Occupation: sales representative.

Event Description

It was reported a patient experienced an unspecified reaction following implantation of a titanium pectus bar.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint is confirmed.The unknown pectus bar was not returned for investigation.Three follow up attempts were made to gather additional information including the identity of the implant that led to the reaction, but no additional information could be gathered.A screenshot of an email was received, which showed a patient post-op with what appeared to be scars from a pectus surgery.The patient's chest was red in the photo.The dhr for the implant involved in this event could not be reviewed due to the identity remaining unknown.There are no indications of manufacturing defects.The complaints and sales histories for the part# involved in this event could not be reviewed to calculate the occurrence rate due to the identity remaining unknown.The most likely underlying cause of the complaint could not be determined, as it was unclear from the information received if this reaction was due to allergies or an infection.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: UNKNOWN TITANIUM PECTUS BAR
• Type of Device: CUSTOM PECTUS BAR
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9521237
• MDR Text Key: 178157672
• Report Number: 0001032347-2019-00581
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• 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: UNK PECTUS BAR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention