MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO VERTAPLEX HV GLOBAL TWIN PK; CEMENT, BONE, VERTEBROPLASTY

Catalog Number	0406622000
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: a follow up report will be filed once the quality investigation is complete.H3 other text : device not available for return.
Event or Problem 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: VERTAPLEX HV GLOBAL TWIN PK
• Common Device Name: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-IRELAND; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA
• Manufacturer Contact: colette chung ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 18826039
• Report Number: 0001811755-2024-00007
• Device Sequence Number: 15390807
• Product Code: NDN
• UDI-Device Identifier: 37613252254431
• UDI-Public: 37613252254431
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K211328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/04/2024

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: 0406622000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2024
• Initial Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: KE058 5.8 MM SPINEJACK EXPANSION KIT, UNKNOWN LOT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown