MAUDE Adverse Event Report: BIOMET MICROFIXATION LORENZ PECTUS SUPPORT BAR; PLATE, FIXATION, BONE

Model Number N/A

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

Patient Problems Adhesion(s) (1695); Death (1802); Injury (2348)

Event Type  Death  

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.Report source: henry, brice lacroix, val´erie pirotte, thierry docquier, pierre-louis (2018) lung middle lobe laceration needing lobectomy as complication of nuss bar removal.Case reports in orthopedics 18, 1-6.Https://doi.Org/10.1155/2018/8965641.

Event Description

It was reported in a journal article that a patient expired at the time of bar removal with autopsy demonstrating ventricular injury and pericardial adhesions.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Based on the information and materials provided, the complaint is confirmed.Functional testing and inspections could not be performed due to the parts not being returned.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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: date of this report.Describe event or problem.Device availability.Date received by manufacturer.Type of report.Follow up type.Device evaluated by manufacturer.Method code.Results code.Conclusions code.Additional narratives/data.

Event Description

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

• Brand Name: LORENZ PECTUS SUPPORT BAR
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8529544
• MDR Text Key: 142421931
• Report Number: 0001032347-2019-00241
• 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: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 08/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2019
• 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: UNKNOWN PECTUS BAR
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Death