MAUDE Adverse Event Report: STRYKER ORTHOBIOLOGICS-MALVERN VITOSS BA2X FOAM PACK 2.5CC; RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICE

Model Number	2102-2102
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/13/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; patient's left foot was revised due to infection (it was not reported to the rep if infection was clinically confirmed).Surgeon reported that the anchorage ii plate was broken.
Additional Manufacturer Narrative
Method: this product was determined to be a concomitant product.Results: this product was determined to be a concomitant product.Conclusion: surgeon does not believe the product contributed to the reported infection therefore this product was determined to be a concomitant product.Report was filed for other product involved under mfr report# 0008031020-2017-00647.
Event or Problem Description
It was reported that; patient's left foot was revised due to infection (it was not reported to the rep if infection was clinically confirmed).Surgeon reported that the anchorage ii plate was broken.

• Brand Name: VITOSS BA2X FOAM PACK 2.5CC
• 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: 7011272
• Report Number: 0002530131-2017-00012
• Device Sequence Number: 16249008
• Product Code: MQV
• UDI-Device Identifier: 00808232000689
• UDI-Public: (01)00808232000689
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 2102-2102
• Device Catalogue Number: 2102-2102
• Device Lot Number: 1602008
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/13/2017
• Supplement Date Received by Manufacturer: 10/13/2017
• Initial Report FDA Received Date: 11/08/2017
• Supplement Report FDA Received Date: 01/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention