MAUDE Adverse Event Report: STRYKER SPINE-US VITOSS BIOACTIVE FOAM STRIP 25X100X8MM; FILLER, BONE VOID, CALCIUM COMPOUND

Model Number	2102-1520
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Remains implanted in the patient.
Event or Problem Description
It was reported that previously implanted vitoss bioactive foam strip "has yet to harden" post-operatively.No further information, adverse consequences, or medical intervention were reported.
Additional Manufacturer Narrative
Additional information received: b.5.Has been updated to reflect that there was no new bone growth.D.6.Date of implant has been populated to (b)(6) 2016.
Event or Problem Description
It was reported that previously implanted vitoss bioactive foam strip "has yet to harden" and there was no new bone growth post-operatively.No further information, adverse consequences, or medical intervention were reported.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained.The root cause of the reported event cannot be determined conclusively from the information provided.Failed fusion may result from incorrect moisture, lack of appropriate composition, expired product used, lack of sufficient surface area, and improper patient selection.
Event or Problem Description
It was reported that previously implanted vitoss bioactive foam strip "has yet to harden" and there was no new bone growth post-operatively.No further information, adverse consequences, or medical intervention were reported.

• Brand Name: VITOSS BIOACTIVE FOAM STRIP 25X100X8MM
• Common Device Name: FILLER, BONE VOID, CALCIUM COMPOUND
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 10374991
• Report Number: 0002530131-2020-00003
• Device Sequence Number: 2160300
• Product Code: MQV
• UDI-Device Identifier: 00808232000481
• UDI-Public: 00808232000481
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K072184
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/23/2020

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: Health Professional
• Device Model Number: 2102-1520
• Device Catalogue Number: 2102-1520
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/08/2020
• Supplement Date Received by Manufacturer: 08/06/2020; 10/30/2020
• Initial Report FDA Received Date: 08/06/2020
• Supplement Report FDA Received Date: 09/03/2020; 11/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1