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

Catalog Number	2102-1605
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/08/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; during a follow up visit the patient presented with an infection.Product was protruding out of the wound.
Additional Manufacturer Narrative
Method: device history review, complaint history review, risk assessment; result: device history review indicated all devices released into final stock met specifications.Device evaluation could not be performed as no items were returned.Conclusion: the root cause could not be determined conclusively and is likely multifactorial.
Event or Problem Description
It was reported that; during a follow up visit, the patient presented with an infection.Product was protruding out of the wound.

• Brand Name: VITOSS BIOACTIVE FOAM PACK 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: 6384294
• Report Number: 0002530131-2017-00003
• Device Sequence Number: 317000
• Product Code: MQV
• UDI-Device Identifier: 00808232000511
• UDI-Public: (01)00808232000511
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2017

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 Expiration Date: 04/28/2018
• Device Catalogue Number: 2102-1605
• Device Lot Number: B1604004
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/08/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2017
• Supplement Report FDA Received Date: 06/01/2017
• 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: Other
• Patient Age: 59 YR