MAUDE Adverse Event Report: STRYKER SPINE-US BIO DBM PUTTY 1CC; RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICE

Catalog Number	7775001
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/18/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; during a one level mis tlif case with doctor, he requested a 2 or 3 cc 's of dbm available to mix with his autograft so as the case began four boxes of 1 cc bio dbm were brought from where it is stored at the hospital.We got to the point where we needed to open graft and two 1cc bio dbm grafts were requested to open to the field.Randomly grabbed two boxes out of the four in the room and handed them to circulator to open.I then left the room to go grab cages to bring in.By the time i got back the graft was open and on the field.I put stickers on my charge sheet and continued with the case.I did not open, or log into the hospital tissue tracking book any of the tracking information.I was notified that one of the grafts we used was expired on 9/15/16.
Additional Manufacturer Narrative
Method: device history review, complaint history review, risk assesment; result: it was confirmed that the product was implanted into a patient past it's expiration date.It was confirmed that the product was manufactured to specification.Conclusion: it is unknown how this occurred.It is possible the hospital staff moved it, but this cannot be confirmed or denied.
Event or Problem Description
It was reported that; during a one level mis tlif case with doctor, he requested a 2 or 3 cc 's of dbm available to mix with his autograft so as the case began four boxes of 1 cc bio dbm were brought from where it is stored at the hospital.We got to the point where we needed to open graft and two 1cc bio dbm grafts were requested to open to the field.Randomly grabbed two boxes out of the four in the room and handed them to circulator to open.I then left the room to go grab cages to bring in.By the time i got back the graft was open and on the field.I put stickers on my charge sheet and continued with the case.I did not open, or log into the hospital tissue tracking book any of the tracking information.I was notified that one of the grafts we used was expired on 9/15/16.

• Brand Name: BIO DBM PUTTY 1CC
• Common Device Name: RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICE
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 6062016
• Report Number: 3004024955-2016-00097
• Device Sequence Number: 10782149
• Product Code: MBP
• UDI-Device Identifier: 07613327177374
• UDI-Public: (01)07613327177374
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 7775001
• Device Lot Number: 1535846547
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/18/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/27/2016
• Supplement Report FDA Received Date: 01/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR