MAUDE Adverse Event Report: BIOMET MICROFIXATION UNKNOWN STAINLESS STEEL PECTUS BAR; UNKNOWN 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.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.Rushing, et al.When it is not an infection: metal allergy after the nuss procedure for repair of pectus excavatum.Journal of pediatric surgery.42:93-97.

Event Description

It was reported in a journal article that the patient experienced an allergic reaction following the implantation of a stainless steel pectus bar.No further information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint is confirmed.A journal article was referenced which evaluated metal allergy and its effects on treatment with the nuss procedure.Over an 18-year period (1987-2005), 862 patients underwent the nuss procedure.Nineteen (2.2%) were diagnosed with metal allergy.Three follow up attempts were made to attempt to gather additional information regarding the identity of the implants in these 19 cases; however, journal article author dr.Goretsky responded that he is unable to provide any additional information regarding the 19 patients with metal allergy referenced in the journal article.The dhrs for the implants involved in these events could not be reviewed due to the identities remaining unknown.There are no indications of manufacturing defects.The complaints and sales histories for the part# involved in these events could not be reviewed to calculate the occurrence rate due to the identities remaining unknown.The most likely underlying cause of the complaint is a patient condition, as these 19 cases were confirmed to be a result of a metal allergy during the study.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 d10 device availability 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.

Event Description

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

• Brand Name: UNKNOWN STAINLESS STEEL PECTUS BAR
• Type of Device: UNKNOWN PECTUS BAR
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9524177
• MDR Text Key: 188984334
• Report Number: 0001032347-2019-00582
• 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: literature
• Type of Report: Initial,Followup
• Report Date: 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/29/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 05/20/2020
• Supplement Dates FDA Received: 05/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention