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

Catalog Number	0909200050
Medical Device Problem Codes	Separation Failure (2547); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a bipedicular spinejack placement at l2 following a tumor ablation, one of the implants would not release from the release rod.The surgeon initially attempted to obtain a stronger grip on the release rod by using a hemostat or kocher, as well as vise grips, and then malleting up from underneath; the blue handle of the release rod came off.The surgeon then injected cement to stabilize the system.After the cement had hardened, release was attempted again, without success.The procedure was completed after a 2-hour delay when the surgeon cut the release rod off at the pedicle.No other medical intervention or adverse consequences were reported, no additional treatment is expected, and the patient is doing well.

• 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: kelsey barla ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 22167812
• Report Number: 3015967359-2025-01091
• Device Sequence Number: 9520494
• Product Code: NDN
• UDI-Device Identifier: 03760253800471
• UDI-Public: (01)03760253800471(17)270930(10)18408-100
• 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: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/09/2025

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 Catalogue Number: 0909200050
• Device Lot Number: 18408-100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2025
• Initial Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2024
• 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