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

Catalog Number 7775001

Device Problem Device Expiration Issue (1216)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/18/2016

Event Type  malfunction  

Event 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.

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 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
• Type of Device: RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICE
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer Contact: rakshya bista ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 6062016
• MDR Text Key: 58927278
• Report Number: 3004024955-2016-00097
• Device Sequence Number: 1
• Product Code: MBP
• UDI-Device Identifier: 07613327177374
• UDI-Public: (01)07613327177374
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 7775001
• Device Lot Number: 1535846547
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2016
• 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 Age: 74 YR