MAUDE Adverse Event Report: ORTHOVITA, INC VITOSS BA2X; BONE FILLER

Catalog Number 2102-2105

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 05/27/2015

Event Type  Injury  

Event Description

On (b)(6) 2016, pt had to undergo surgery due to painful hardware in shoulder.

• Brand Name: VITOSS BA2X
• Type of Device: BONE FILLER
• Manufacturer (Section D): ORTHOVITA, INC
• MDR Report Key: 5675340
• MDR Text Key: 45862565
• Report Number: MW5062447
• Device Sequence Number: 0
• Product Code: MQV
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 05/19/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Catalogue Number: 2102-2105
• Device Lot Number: B1403011
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/19/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 57 YR