MAUDE Adverse Event Report: STRYKER SPINE-US VITOSS BA2X FOAM PACK 2.5CC; FILLER, BONE VOID, CALCIUM COMPOUND

Catalog Number	2102-2102
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	11/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 other text: device remains implanted.
Event or Problem Description
A patient was implanted, with a variax plate, variax screws, a 2.5 cc vitoss ba2x foam pack.And 15 cc hydroset xt in their foot, following removal of a bone mass.Beginning approximately, four-months post-operatively.The patient reported, experiencing "severe foot pain" and difficulty walking.This report captures, the 2.5 cc vitoss ba2x foam pack.
Additional Manufacturer Narrative
H6 coding has been updated to reflect completion of the investigation.
Event or Problem Description
A patient was implanted with a variax plate, variax screws, a 2.5 cc vitoss ba2x foam pack, and 15 cc hydroset xt in their foot following removal of a bone mass.Beginning approximately four-months post-operatively, the patient reported experiencing "severe foot pain" and difficulty walking.This report captures the 2.5 cc vitoss ba2x foam pack.

• Brand Name: VITOSS BA2X FOAM PACK 2.5CC
• Common Device Name: FILLER, BONE VOID, CALCIUM COMPOUND
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 18804145
• Report Number: 3004024955-2024-00003
• Device Sequence Number: 15239716
• Product Code: MQV
• UDI-Device Identifier: 00808232000689
• UDI-Public: 00808232000689
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K102545
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 2102-2102
• Device Lot Number: B2001013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/29/2024
• Initial Report FDA Received Date: 02/28/2024
• Supplement Report FDA Received Date: 03/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Other
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 75 KG