MAUDE Adverse Event Report: STRYKER ORTHOBIOLOGICS-MALVERN VITOSS FOAM FLOW 5CC; RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICE.

Catalog Number	2102-1305
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/10/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a piece of 2102-1305, lot # b1310001 which was expired on 10/31/2016 was implanted into a patient on (b)(6) 2016.
Additional Manufacturer Narrative
Method: device history review; complaint history review; risk assessment; results: device history review indicated all devices accepted into final stock met specifications.Device evaluation could not be performed as no items were returned.Conclusion: based on the reported event and additional information gathered, the most likely cause of the reported event was determined to be user/hospital error.
Event or Problem Description
It was reported that a piece of 2102-1305, lot # b1310001 which was expired on 10/31/2016 was implanted into a patient on (b)(6) 2016.

• Brand Name: VITOSS FOAM FLOW 5CC
• 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: 6148560
• Report Number: 0002530131-2016-00018
• Device Sequence Number: 16362914
• Product Code: MQV
• UDI-Device Identifier: 00808232000375
• UDI-Public: (01)00808232000375
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 04/27/2017

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 Expiration Date: 10/31/2016
• Device Catalogue Number: 2102-1305
• Device Lot Number: B1310001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/10/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/06/2016
• Supplement Report FDA Received Date: 04/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1