MAUDE Adverse Event Report: STRYKER ORTHOBIOLOGICS-MALVERN VITOSS BIOACTIVE FOAM PACK 1.2CC; RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICE

Catalog Number	2102-1601
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	08/17/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an expired product was implanted into patient.
Additional Manufacturer Narrative
Device history review indicated all devices accepted into final stock met specifications.Device evaluation could not be performed as no items were returned.Complaint history review indicated there have been no other similar complaints for this reported lot.Based on the reported event, the likely root cause of the reported event was determined to be user error.It's likely that the expiration date was not checked before and/or during the procedure that could have led for this product to be used in surgery.The probable root cause is user error.
Event or Problem Description
It was reported that an expired product was implanted into patient.

• Brand Name: VITOSS BIOACTIVE FOAM PACK 1.2CC
• Common Device Name: RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICE
• Manufacturer (Section D): STRYKER ORTHOBIOLOGICS-MALVERN; 45 great valley parkway; malvern PA 19355
• MDR Report Key: 5951327
• Report Number: 0002530131-2016-00015
• Device Sequence Number: 705143
• Product Code: MQV
• UDI-Device Identifier: 00808232000498
• UDI-Public: (01)00808232000498
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2016

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 Expiration Date: 07/31/2016
• Device Catalogue Number: 2102-1601
• Device Lot Number: B1407015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/17/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/14/2016
• Supplement Report FDA Received Date: 11/18/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1