MAUDE Adverse Event Report: MUSCULOSKELETAL TRANSPLANT FOUNDATION DBX PUTTY , 5CC (DEMINERALIZED BONE MATRIX); BONE VOID FILLER

Catalog Number 038050

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 06/10/2016

Event Type  Death  

Manufacturer Narrative

Donor eligibility was determined by the medical director on (b)(6) 2015.Donor complies.Relevant communicable infectious disease serology testing were nonreactive.The batch record review associated with the production of the complaint unit showed no evidence of errors, discrepancies, omissions or cgtp violations.Units associated with this donor were released as per mtf specifications.Tissue in-process bioburden and final sterility cultures are negative for growth.Environmental data was reviewed.All locations were in control.There have been no other adverse events received for this donor.The case details and investigation findings were reviewed by mtf's medical director who found no evidence to indicate that the device caused or contributed to this event.Device implanted.

Event Description

It was reported patient expired two days post-surgery.Patient underwent a transforaminal posterior lumbar interbody fusion (tplif) from l5-s1 for central stenosis on (b)(6) 2016.Surgery was successfully completed with no complications.Patient was last checked at night on (b)(6) 2016 and was reported as stable.The nurse revisited the patient in the morning (unknown time) on (b)(6) 2016 and patient was coded.Patient is an organ donor and his heart and tissues were harvested.Autopsy results have not been provided to surgeon at this time.Surgeon suspected heart attack however, it is unknown if patient had pre-existing heart issues." reporter states autopsy report will be available at a later date.

Manufacturer Narrative

Donor eligibility was determined by the medical director on 4/21/2015.Donor complies.Relevant communicable infectious disease serology testing were nonreactive.The batch record review associated with the production of the complaint unit showed no evidence of errors, discrepancies, omissions or cgtp violations.Units associated with this donor were released as per mtf specifications.Tissue in-process bioburden and final sterility cultures are negative for growth.Environmental data was reviewed.All locations were in control.There have been no other adverse events received for this donor.The case details and investigation findings were reviewed by mtf's medical director who found no evidence to indicate that the device caused or contributed to this event.On 10/4/2015: despite numerous attempts, an autopsy report was unable to be obtained.A total of (b)(4) dbx units were produced from donor (b)(6), all were distributed.There are 12 tissue trace records on file for the dbx units.As per mtf's medical director (dr.(b)(6)): "report of sudden cardiac death 2 days post op, no report of infection, donor met all criteria, no evidence to link cause of death to graft." conclusion: the case details and investigation findings were reviewed by mtf's medical director who found no evidence to indicate that the device caused or contributed to this event.This investigation is considered closed.

Event Description

It was reported patient expired two days post-surgery.Patient underwent a transforaminal posterior lumbar interbody fusion (tplif) from l5-s1 for central stenosis on (b)(6) 2016.Surgery was successfully completed with no complications.Patient was last checked at night on (b)(6) 2016 and was reported as stable.The nurse revisited the patient in the morning (unknown time) on (b)(6) 2016 and patient was coded.Patient is an organ donor and his heart and tissues were harvested.Autopsy results have not been provided to surgeon at this time.Surgeon suspected heart attack however, it is unknown if patient had pre-existing heart issues." reporter states autopsy report will be available at a later date.

• Brand Name: DBX PUTTY , 5CC (DEMINERALIZED BONE MATRIX)
• Type of Device: BONE VOID FILLER
• Manufacturer (Section D): MUSCULOSKELETAL TRANSPLANT FOUNDATION; 125 may street; edison NJ 08837
• Manufacturer (Section G): MUSCULOSKELETAL TRANSPLANT FOUNDATION; 125 may street; edison NJ 08837
• Manufacturer Contact: mary agostisi ; 125 may street; edison, NJ 08837 ; 7326613160
• MDR Report Key: 5823018
• MDR Text Key: 50472619
• Report Number: 2249062-2016-00002
• Device Sequence Number: 1
• Product Code: MBP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040262
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/28/2016

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
• Device Operator: No Information
• Device Expiration Date: 01/21/2018
• Device Catalogue Number: 038050
• Device Lot Number: 11210023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/28/2016
• Initial Date FDA Received: 07/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/04/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/21/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 46 YR