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

Model Number	0909200058
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a bipedicular implant procedure the expansion assembly on one side seemed to advance further than expected within the access cannula, presenting the potential for the implant to also reach an excessive depth within the vertebral body.There was no report of the implant actually reaching an excessive depth.The procedure was completed successfully without a clinically-significant delay and no medical intervention or adverse consequences were reported.
Event or Problem Description
It was reported that during a bipedicular implant procedure the expansion assembly on one side seemed to advance further than expected within the access cannula, presenting the potential for the implant to also reach an excessive depth within the vertebral body.There was no report of the implant actually reaching an excessive depth.The procedure was completed successfully without a clinically-significant delay and no medical intervention or adverse consequences were reported.
Additional Manufacturer Narrative
Follow-up report submitted to document device evaluation results.

• 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: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 16993811
• Report Number: 3015967359-2023-01171
• Device Sequence Number: 7039867
• Product Code: NDN
• UDI-Device Identifier: 03760253800495
• UDI-Public: 03760253800495
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 10/10/2023

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 Model Number: 0909200058
• Device Catalogue Number: 0909200058
• Device Lot Number: 2022050335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2023
• Supplement Date Received by Manufacturer: 10/10/2023
• Initial Report FDA Received Date: 05/24/2023
• Supplement Report FDA Received Date: 10/10/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 0909100058 LOT 16147-150 (PREP KIT)
• Patient Sex: Unknown