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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OSTEOTECH. INC GRAFTON DBM BONE GRAFTING MATERIAL, HUMAN SOURCE

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OSTEOTECH. INC GRAFTON DBM BONE GRAFTING MATERIAL, HUMAN SOURCE Back to Search Results
Catalog Number T43110INT
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 11/28/2018
Event Type  Injury  
Manufacturer Narrative
As per the hcp review it was unlikely that the product caused the infection. Manufacturing assessment- the non-conformance database was reviewed and there were no non-conformances found for (b)(4)/t43110int. The donor charts revealed-no deviations from sop, supplies were in compliance and recovery was performed in time and temperature limits. Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation. Therefore, we are unable to determine the definitive cause of the reported event. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Procedure: lumbar arthrodesis, laminectomy with decompression, lateral spinal canal scan for foraminotomy bilateral, lumbar disc excision, demineralized bone matrix application in anterior and posterior lumbar spine level implanted: l4-l5/l5-s1 it was reported that post-op, patient had infection on the operating site requiring surgical management and vac implant. Patient currently is in treatment for the infection with antibiotics. Patient was on antibiotics at the time of event.
 
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Brand NameGRAFTON DBM
Type of DeviceBONE GRAFTING MATERIAL, HUMAN SOURCE
Manufacturer (Section D)
OSTEOTECH. INC
201 industrial way west
eatontown NJ 07724
Manufacturer (Section G)
OSTEOTECH. INC
201 industrial way west
eatontown NJ 07724
Manufacturer Contact
stacie ziemba
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key8325390
MDR Text Key135704080
Report Number2246640-2019-00001
Device Sequence Number1
Product Code NUN
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K051188
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/01/2021
Device Catalogue NumberT43110INT
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 Received02/19/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/02/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/11/2019 Patient Sequence Number: 1
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