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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MTFDBX DEMINERALIZED BONE MATRIX, 10 CCBONE VOID FILLER CONTAINING DEMINERALIZED HUMAN TISSUE

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MTF DBX DEMINERALIZED BONE MATRIX, 10 CC BONE VOID FILLER CONTAINING DEMINERALIZED HUMAN TISSUE   Back to Search Results
Catalog Number 038100
Event Date 11/16/2005
Event Type  Other   Patient Outcome  Other
Manufacturer Narrative

The lot number of the glass barrels was 127011105002e, manufactured by ispg, inc. No other complaints have been received regarding other devices from this serial number.

 
Event Description

When devices were removed from outer packing, the inner package (glass barrels) broke in half.

 
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Brand NameDBX DEMINERALIZED BONE MATRIX, 10 CC
Type of DeviceBONE VOID FILLER CONTAINING DEMINERALIZED HUMAN TISSUE
Baseline Brand NameDBX PUTTY
Baseline Generic NameRESORBABLE BONE VOID FILLER CONTAINING DEMINERALIZED IN HUMAN BONE IN A CARRIER
Baseline Catalogue Number038100
Baseline Device FamilyDBX DEMINERALIZED BONE MATRIX
Baseline Device 510(K) NumberK040262
Baseline Shelf Life Information Yes
Is Baseline PMA Number Provided? No
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)24
Manufacturer (Section F)
MTF
edison NJ 08837
Manufacturer (Section D)
MTF
edison NJ 08837
Manufacturer Contact
karen hardwick
125 may st
edison , NJ 08837
(732) 661 -2354
Device Event Key645415
MDR Report Key655927
Event Key623949
Report Number2249062-2005-00001
Device Sequence Number1
Product CodeMQV
Report Source Manufacturer
Source Type User facility,Company Representative
Reporter Occupation Nurse
Type of Report Initial
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/02/2005
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date04/01/2007
Device Catalogue Number038100
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/16/2005
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/01/2005
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? Yes
Is this an Explanted Device? No Answer Provided
Type of Device Usage Initial

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