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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTERPORE CROSS INTERNATIONAL DBM AND MINERALIZED ALLOGRAFT IN A LECITHIN CARRIER BONE GRAFT

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INTERPORE CROSS INTERNATIONAL DBM AND MINERALIZED ALLOGRAFT IN A LECITHIN CARRIER BONE GRAFT Back to Search Results
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.
 
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Brand NameDBM AND MINERALIZED ALLOGRAFT IN A LECITHIN CARRIER
Type of DeviceBONE 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 Key10898112
MDR Text Key218253168
Report Number0001038806-2020-01857
Device Sequence Number1
Product Code NUN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113645
Number of Events Reported1
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 Received11/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/24/2022
Device Catalogue NumberROAPM20
Device Lot Number995810
Was Device Available for Evaluation? No
Date Returned to Manufacturer11/17/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/24/2020
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
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