MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO VERTAPLEX HV SINGLE PACK; CEMENT, BONE, VERTEBROPLASTY

Model Number	0406622015
Medical Device Problem Codes	Improper Flow or Infusion (2954); Thickening of Material (4056)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device discarded by customer.
Event or Problem Description
It was reported that during a surgical procedure, the cement viscosity was too high and caused the delivery cannula to get stuck in the patient.It was further reported that the event caused a delay leading to prolonged surgical time and longer time under anesthesia for the patient.It was also reported that the surgeon performed a spondylodesis (spinal fusion) to complete the procedure.It was further reported that a part of the guide sleeve remained in the patient.It was also reported that the procedure was completed successfully.
Event or Problem Description
It was reported that during a surgical procedure, the cement viscosity was too high and caused the delivery cannula to get stuck in the patient.It was further reported that the event caused a delay leading to prolonged surgical time and longer time under anesthesia for the patient.It was also reported that the surgeon performed a spondylodesis(spinal fusion) to complete the procedure.It was further reported that a part of the guide sleeve remained in the patient.It was also reported that the procedure was completed successfully.
Additional Manufacturer Narrative
H6: the quality investigation is complete.H3 other text : device not available for return.

• Brand Name: VERTAPLEX HV SINGLE PACK
• 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: una barry ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 14322672
• Report Number: 0001811755-2022-00017
• Device Sequence Number: 17308664
• Product Code: PML
• UDI-Device Identifier: 07613327170559
• UDI-Public: 07613327170559
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K192818
• 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,Followup
• Report Date (Section B): 07/14/2022

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 Model Number: 0406622015
• Device Catalogue Number: 0406622015
• Device Lot Number: VKC069
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/10/2022
• Supplement Date Received by Manufacturer: 07/06/2022
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 07/14/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown