MAUDE Adverse Event Report: STRYKER SPINE-US HYDROSET XT FINAL KIT 15CC; FILLER, BONE VOID, CALCIUM COMPOUND

Catalog Number 897015

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Ambulation Difficulties (2544)

Event Date 11/01/2021

Event Type  Injury  

Event 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 15 cc hydroset xt.

Manufacturer Narrative

H3 other text: device remains implanted.

Event 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 15 cc hydroset xt.

Manufacturer Narrative

H6 coding has been updated to reflect completion of the investigation.

• Brand Name: HYDROSET XT FINAL KIT 15CC
• Type of Device: 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: 18804141
• MDR Text Key: 336507820
• Report Number: 3004024955-2024-00004
• Device Sequence Number: 1
• Product Code: MQV
• UDI-Device Identifier: 07613327064292
• UDI-Public: 07613327064292
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 897015
• Device Lot Number: IC03099
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 50 YR
• Patient Sex: Female
• Patient Weight: 75 KG