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

Catalog Number KE001

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 03/07/2024

Event Type  Injury  

Event Description

It was reported that during a percutaneous kyphoplasty using spinejack, the neurosurgeon was unable to deply the end of the spinejack and the plastic end broke.The surgical procedure was modified and it was reported that the right side was unable to be cemented.Additional information has been requested regarding the event and the patient status.

Manufacturer Narrative

H3 other text : confirming product availability.

Manufacturer Narrative

Corrected data: d9/h3.Follow-up report submitted to document quality investigation results.H3 other text : device not returned.

Event Description

It was reported that during a percutaneous kyphoplasty using spinejack, the neurosurgeon was unable to deply the end of the spinejack and the plastic end broke.The surgical procedure was modified and it was reported that the right side was unable to be cemented.Although requested, no additional information was provided.

• Brand Name: 5.0 MM SPINEJACK EXPANSION KIT
• Type of Device: 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: 18975173
• MDR Text Key: 338554214
• Report Number: 3015967359-2024-00553
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K223294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: KE001
• Device Lot Number: 17802-300
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other