MAUDE Adverse Event Report: STRYKER SPINE-US VITOSS BA2X FOAM PACK 10CC; FILLER, BONE VOID, CALCIUM COMPOUND

Model Number	2102-2110
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not returned.
Event or Problem Description
A company representative reported that a 10 cc unit of vitoss ba2x foam migrated into the soft tissue in the patient's heel post-operatively.The physician, "numbed [the patient] up in the office, opened it, and cleaned 90% of it out.".

• Brand Name: VITOSS BA2X FOAM PACK 10CC
• Common Device Name: FILLER, BONE VOID, CALCIUM COMPOUND
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER ORTHOBIOLOGICS-MALVERN; 45 great valley parkway; malvern PA 19355
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 16791592
• Report Number: 0002530131-2023-00001
• Device Sequence Number: 5523098
• Product Code: MQV
• UDI-Device Identifier: 00808232000702
• UDI-Public: 00808232000702
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K102545
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/21/2023

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: Health Professional
• Device Expiration Date: 04/28/2024
• Device Model Number: 2102-2110
• Device Catalogue Number: 2102-2110
• Device Lot Number: B2205032
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2023
• Initial Report FDA Received Date: 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 28 YR
• Patient Sex: Male