MAUDE Adverse Event Report: STRYKER SPINE-US BIO DBM PUTTY 10CC; RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICE

Model Number	7775010
Medical Device Problem Code	Device Damaged Prior to Receipt by User (1570)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	04/18/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; dr.Booked lumbar fusion and said must used dbm putty.We ordered dbm putty last week for case but the 10cc putty we ordered was on b/o so we didn't receive that.We had 20cc total (5cc size), so as a back up we had a courier bring 10cc putty from (b)(6) the morning of (b)(6) 2017.As the case went on we opened all 5cc sizes and dr.Said he needed more so then the borrowed 10cc was opened for case.This was done so before the hospital could input the product in their system.Later on in day we got a call from hospital asking where we got the dbm from.Rep explained how we got the product, that a piece of tissue was transferred from one hospital to another.
Event or Problem Description
It was reported that; dr.(b)(6) lumbar fusion and said must used dbm putty.We ordered dbm putty last week for case but the 10cc putty we ordered was on b/o so we didn't receive that.We had 20cc total (5cc size), so as a back up we had a courier bring 10cc putty from (b)(6) the morning of (b)(6) 2017.As the case went on we opened all 5cc sizes and dr.Said he needed more so then the borrowed 10cc was opened for case.This was done so before the hospital could input the product in their system.Later on in day we got a call from hospital asking where we got the dbm from.Rep explained how we got the product, that a piece of tissue was transferred from one hospital to another.

• Brand Name: BIO DBM PUTTY 10CC
• 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: 6522682
• Report Number: 3004024955-2017-00018
• Device Sequence Number: 19010891
• Product Code: MBP
• UDI-Device Identifier: 07613327177398
• UDI-Public: (01)07613327177398
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2018

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 Model Number: 7775010
• Device Catalogue Number: 7775010
• Device Lot Number: 1571706528
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/18/2017
• Supplement Date Received by Manufacturer: 04/18/2017
• Initial Report FDA Received Date: 04/26/2017
• Supplement Report FDA Received Date: 01/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1