MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SPINEJACK EXPANSION KIT 5.0MM; CEMENT, BONE, VERTEBROPLASTY

Model Number	0909200050
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a vertebroplasty procedure at t11, a spinejack implant was being manipulated by the surgeon.The surgeon attempted to remove the spinejack implant, resistance was noted, and the surgeon stopped.Upon removal of the expander tube, it was found the implant had released subcutaneously in the patient tissue, and it was noted there was no extravasation of cement.The surgeon made a larger incision and surgically removed the implant from the patient tissue.No clinically significant delay occurred, and the procedure was completed successfully.The cement fill was reported to be adequate in the vertebroplasty, and no additional follow up or medical intervention has been indicated.
Event or Problem Description
It was reported that during a vertebroplasty procedure at t11, a spinejack implant was being manipulated by the surgeon.The surgeon attempted to remove the spinejack implant, resistance was noted, and the surgeon stopped.Upon removal of the expander tube, it was found the implant had released subcutaneously in the patient tissue, and it was noted there was no extravasation of cement.The surgeon made a larger incision and surgically removed the implant from the patient tissue.No clinically significant delay occurred, and the procedure was completed successfully.The cement fill was reported to be adequate in the vertebroplasty, and no additional follow up or medical intervention has been indicated.

• Brand Name: SPINEJACK EXPANSION KIT 5.0MM
• 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: 15640453
• Report Number: 3015967359-2022-01956
• Device Sequence Number: 6518849
• Product Code: NDN
• UDI-Device Identifier: 03760253800471
• UDI-Public: 03760253800471
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K181262
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2023

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: 0909200050
• Device Catalogue Number: 0909200050
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/23/2022
• Supplement Date Received by Manufacturer: 02/21/2023
• Initial Report FDA Received Date: 10/20/2022
• Supplement Report FDA Received Date: 02/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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