MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 5.8 MM SPINEJACK PREPARATION KIT; TAMP

Catalog Number KP058

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/05/2024

Event Type  Injury  

Manufacturer Narrative

H3 other text : device remains implanted.

Event Description

It was reported that during a spinejack procedure at t11, the radiopaque marker from the cannula plug remained in the vertebral body of the patient.The surgeon was able to position the spinejacks.Upon cement injection from the left, a rapidly significant leakage of cement was observed requiring immediate surgical intervention to remove the leaked cement.The operation lasted an extra 2 hours.The patient's condition was clear on discharge (d+2) following extraction of the foreign body (leaked cement).

Manufacturer Narrative

Section e, initial reporter address the quality investigation is complete.

Event Description

It was reported that during a spinejack procedure at t11, the radiopaque marker from the cannula plug remained in the vertebral body of the patient.The surgeon was able to position the spinejacks.Upon cement injection from the left, a rapidly significant leakage of cement was observed requiring immediate surgical intervention to remove the leaked cement.The operation lasted an extra 2 hours.The patient's condition was clear on discharge (d+2) following extraction of the foreign body (leaked cement).

• Brand Name: 5.8 MM SPINEJACK PREPARATION KIT
• Type of Device: TAMP
• 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: 18711983
• MDR Text Key: 335476222
• Report Number: 3015967359-2024-00390
• Device Sequence Number: 1
• Product Code: HXG
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: KP058
• Device Lot Number: 17660-100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: KE058 5.8 MM SPINEJACK EXPANSION KIT, UNKNOWN LOT
• Patient Outcome(s): Required Intervention