MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2016-07-26 for DBX PUTTY , 5CC (DEMINERALIZED BONE MATRIX) 038050 manufactured by Musculoskeletal Transplant Foundation.
[50472619]
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.
Patient Sequence No: 1, Text Type: N, H10
[50472620]
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.
Patient Sequence No: 1, Text Type: D, B5
[56556831]
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.
Patient Sequence No: 1, Text Type: N, H10
[56556832]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2249062-2016-00002 |
| MDR Report Key | 5823018 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2016-07-26 |
| Date of Report | 2016-06-28 |
| Date of Event | 2016-06-10 |
| Date Mfgr Received | 2016-06-28 |
| Device Manufacturer Date | 2016-01-21 |
| Date Added to Maude | 2016-07-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS MARY AGOSTISI |
| Manufacturer Street | 125 MAY STREET |
| Manufacturer City | EDISON NJ 08837 |
| Manufacturer Country | US |
| Manufacturer Postal | 08837 |
| Manufacturer Phone | 7326613160 |
| Manufacturer G1 | MUSCULOSKELETAL TRANSPLANT FOUNDATION |
| Manufacturer Street | 125 MAY STREET |
| Manufacturer City | EDISON NJ 08837 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 08837 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DBX PUTTY , 5CC (DEMINERALIZED BONE MATRIX) |
| Generic Name | BONE VOID FILLER |
| Product Code | MBP |
| Date Received | 2016-07-26 |
| Catalog Number | 038050 |
| Lot Number | 11210023 |
| Device Expiration Date | 2018-01-21 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MUSCULOSKELETAL TRANSPLANT FOUNDATION |
| Manufacturer Address | 125 MAY STREET EDISON NJ 08837 US 08837 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2016-07-26 |