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

Model Number 7775010

Device Problems Shipping Damage or Problem (1570); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 04/18/2017

Event Type  malfunction  

Event 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 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
• 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: marta koutsogiannis ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 6522682
• MDR Text Key: 74015824
• Report Number: 3004024955-2017-00018
• Device Sequence Number: 1
• Product Code: MBP
• UDI-Device Identifier: 07613327177398
• UDI-Public: (01)07613327177398
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 7775010
• Device Catalogue Number: 7775010
• Device Lot Number: 1571706528
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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