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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLLAGEN MATRIX, INC. REGENEROSS RESORBABLE XENOGRAFT; PORCINE ANORGANIC BONE MINERAL
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COLLAGEN MATRIX, INC. REGENEROSS RESORBABLE XENOGRAFT; PORCINE ANORGANIC BONE MINERAL Back to Search Results
Catalog Number ROXR05
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Date of Event 04/27/2019
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that a clinician used the porcine xenograft along with puros particulate allograft and a biomend absorbale collagen membrane.The patient returned after 5 months for implant placement.The clinician reported to be unhappy with the outcome of the bone augmentation and the implant was unable to be placed.
 
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Brand Name
REGENEROSS RESORBABLE XENOGRAFT
Common Device Name
PORCINE ANORGANIC BONE MINERAL
Manufacturer (Section D)
COLLAGEN MATRIX, INC.
15 thornton road
oakland NJ 07436
MDR Report Key9208314
Report Number2249852-2019-00021
Device Sequence Number449179
Product Code NPM
UDI-Device Identifier00813954022338
UDI-Public00813954022338
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K140714
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Reporter Type Manufacturer
Report Source distributor,health profession
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 10/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date04/30/2021
Device Catalogue NumberROXR05
Device Lot NumberPMCU18C4
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/18/2019
Initial Report FDA Received Date10/18/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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