MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SPINEJACK EXPANSION KIT 5.8MM; CEMENT, BONE, VERTEBROPLASTY

Catalog Number	0909200058
Medical Device Problem Codes	Separation Failure (2547); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a bipedicular implant procedure at t12, one of the spinejack implants experienced a lot of pressure due to hard bone and would not expand.Additionally, the same implant would not release from the release pin.The procedure was completed successfully as a unipedicular case with only cement injected on one side.No delay, medical intervention, or adverse consequences were reported.
Additional Manufacturer Narrative
Follow-up report submitted to document quality investigation results.
Event or Problem Description
It was reported that during a bipedicular implant procedure at t12, one of the spinejack implants experienced a lot of pressure due to hard bone and would not expand.Additionally, the same implant would not release from the release pin.The procedure was completed successfully as a unipedicular case with only cement injected on one side.No delay, medical intervention, or adverse consequences were reported.

• Brand Name: SPINEJACK EXPANSION KIT 5.8MM
• 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: kelsey barla ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 20480511
• Report Number: 3015967359-2024-01923
• Device Sequence Number: 12785133
• Product Code: NDN
• UDI-Device Identifier: 03760253800495
• UDI-Public: (01)03760253800495(17)261231(10)18049-200
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K223294
• 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): 01/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0909200058
• Device Lot Number: 18049-200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/03/2024
• Supplement Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 10/18/2024
• Supplement Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/31/2023
• 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
• Patient Sex: Unknown