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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 ALLOGRAFT PUTTY

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INTERPORE CROSS INTERNATIONAL DBM AND MINERALIZED ALLOGRAFT IN A LECITHIN CARRIER ALLOGRAFT PUTTY Back to Search Results
Catalog Number ROAPM20
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Pain (1994)
Event Date 05/30/2017
Event Type  Injury  
Manufacturer Narrative
One product unit of roapm20, lot 009050, was evaluated for its characteristics. The visual characteristics color, mixture and uniformity appeared normal for roapm product. The handling characteristics were very good. The putty was moldable to various shapes, and typical for roapm product. A device history review was performed and no related non-conformances were noted. Roapm20 ¿ lot 009050 was produced using dbm lot odb-0221600, cancellous lot oba-0221600 and carrier lot 313600. Shop order record indicates that the mixing formulation, dbm, and carrier type are correct. Handling evaluation of the lot sample, as part of the lot release requirements, is acceptable. The complaint was not verifiable, as there were no manufacturing deviations identified with the lot that could cause or contribute to the reported event. Roapm20, lot 009050, was found to have acceptable handling and manufacturing characteristics. No probable cause could be determined.
 
Manufacturer Narrative
Device was discarded by the customer.
 
Event Description
The doctor reported that a patient had immediate socket grafting (roapm20) done in tooth location #13 on (b)(6) 2017. The patient returned on (b)(6) 2017 with severe pain, similar to dry socket pain. Loss of graft/non-integration was evident despite covering the site with crisscross sutures & resorbable collagen dressing. The extraction of the allograft was straight forward.
 
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Brand NameDBM AND MINERALIZED ALLOGRAFT IN A LECITHIN CARRIER
Type of DeviceALLOGRAFT PUTTY
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
dania perez
4555 riverside drive
palm beach gardens, FL 33410
5617766700
MDR Report Key6716660
MDR Text Key262603729
Report Number0001038806-2017-00423
Device Sequence Number1
Product Code NUN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK113645
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 10/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberROAPM20
Device Lot Number009050
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/02/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 07/17/2017 Patient Sequence Number: 1
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