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

Catalog Number 2102-1605

Device Problems Biocompatibility (2886); Material Protrusion/Extrusion (2979)

Patient Problem Unspecified Infection (1930)

Event Date 02/08/2017

Event Type  Injury  

Event Description

It was reported that; during a follow up visit the patient presented with an infection.Product was protruding out of the wound.

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 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
• Type of Device: RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICE
• Manufacturer (Section D): STRYKER ORTHOBIOLOGICS-MALVERN; 45 great valley parkway; malvern PA 19355
• Manufacturer (Section G): STRYKER ORTHOBIOLOGICS-MALVERN; 45 great valley parkway; malvern PA 19355
• Manufacturer Contact: rakshya bista ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 6384294
• MDR Text Key: 69261932
• Report Number: 0002530131-2017-00003
• Device Sequence Number: 1
• Product Code: MQV
• UDI-Device Identifier: 00808232000511
• UDI-Public: (01)00808232000511
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/28/2018
• Device Catalogue Number: 2102-1605
• Device Lot Number: B1604004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR