MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SPINEJACK EXPANSION KIT 4.2MM; CEMENT, BONE, VERTEBROPLASTY

Model Number	0909200042
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that at the end of a procedure involving ablation of the patient's tumor and implantation of spinejack at the tumor location, the physician had difficulty separating the expander tube from the deployed spinejack implant.The physician was able to detach the expander tube by pulling the implant back towards the patient's pedicle and then used a trocar to push the spinejack implant and cement back into the vertebral body.The procedure was completed successfully with a 25-30 minute delay and no additional medical intervention or adverse consequences have been reported.
Additional Manufacturer Narrative
Device not returned.

• Brand Name: SPINEJACK EXPANSION KIT 4.2MM
• Common Device Name: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 16241590
• Report Number: 3015967359-2023-00095
• Device Sequence Number: 6406619
• Product Code: NDN
• UDI-Device Identifier: 03760253800488
• UDI-Public: 03760253800488
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K223294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/25/2023

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 Model Number: 0909200042
• Device Catalogue Number: 0909200042
• Device Lot Number: 16703110
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/28/2022
• Initial Report FDA Received Date: 01/25/2023
• 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: Required Intervention
• Patient Sex: Unknown