MAUDE Adverse Event Report: INTERPORE CROSS INTERNATIONAL 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.

• Brand Name: DBM AND MINERALIZED ALLOGRAFT IN A LECITHIN CARRIER
• Type of Device: BONE GRAFT
• Manufacturer (Section D): INTERPORE CROSS INTERNATIONAL; 181 technology drive; irvine CA 92618 2402
• Manufacturer (Section G): INTERPORE CROSS INTERNATIONAL; 181 technology drive; irvine CA 92618 2402
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• 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
• Reporter Country Code: US
• PMA/PMN Number: K113645
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• 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

• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 03/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2020
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Invalid Data

Patient Treatment Data

Date Received: 11/24/2020 Patient Sequence Number: 1