MAUDE Adverse Event Report: DBM AND MINERALIZED ALLOGRAFT IN A LECITHIN CARRIER; BONE GRAFT

Catalog Number ROAPM20

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

Patient Problems Fistula (1862); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Swelling (2091)

Event Date 10/27/2020

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).

Event Description

Customer reported tooth site #30, graft placed (b)(6) 2020.Patient reported swelling in graft site shortly after surgery.Patient had fistula and possible infection.Doctor saw patient on post op to manage area and looking for possible causes.Unsure if it is the graft material.Graft was removed (b)(6) 2020.

Manufacturer Narrative

This report is being submitted to relay additional information.The following sections are being reported: h6: type of investigation was added: 3331.H6: investigation findings was added: 213.H6: investigation conclusions was added: 4310.The dhr was reviewed for the affected lot # 995810 (ref: wo # 995810, roapm20) and no deviation/anomaly was detected during the manufacturing process.The affected lot was conforming when it had left zimmmer biomet irvine facility.Product was not returned to zb site for further evaluation.A definitive root cause for the reported event could not be determined.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

No additional or corrected information to report.

• Brand Name: DBM AND MINERALIZED ALLOGRAFT IN A LECITHIN CARRIER
• Type of Device: BONE GRAFT
• MDR Report Key: 10898112
• MDR Text Key: 218253168
• Report Number: 0001038806-2020-01857
• Device Sequence Number: 1
• Product Code: NUN
• Combination Product (y/n): N
• PMA/PMN Number: K113645
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/24/2022
• Device Catalogue Number: ROAPM20
• Device Lot Number: 995810
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/17/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention