MAUDE Adverse Event Report: STRYKER ORTHOBIOLOGICS-MALVERN VITOSS BIMODAL FOAM PACK 10CC; RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICE

Model Number	2102-1910
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/25/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; expired product was opened and implanted.
Additional Manufacturer Narrative
Results: the device was not returned and not lot# was provided therefore, device inspection, functional and complaint history could not be performed.Conclusion: based on the reported event, the likely root cause of the reported event was determined to be user error.
Event or Problem Description
It was reported that; expired product was opened and implanted.

• Brand Name: VITOSS BIMODAL FOAM PACK 10CC
• 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: 6671683
• Report Number: 0002530131-2017-00008
• Device Sequence Number: 16161247
• Product Code: MQV
• UDI-Device Identifier: 00808232000658
• UDI-Public: (01)00808232000658
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2017

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 Model Number: 2102-1910
• Device Catalogue Number: 2102-1910
• Device Lot Number: B1504009
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/30/2017
• Supplement Date Received by Manufacturer: 05/30/2017
• Initial Report FDA Received Date: 06/27/2017
• Supplement Report FDA Received Date: 08/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1