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

Model Number	0406622015
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after a surgical procedure, it was noted that the surgeon knowingly used expired product.It was also reported there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.This report is addressing the sterility risk associated with such an event.
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Product used/implemented in patient.
Additional Manufacturer Narrative
E1: initial reporter contact details updated.H6: the quality investigation is complete.H3 other text : device not returned.
Event or Problem Description
It was reported that after a surgical procedure, it was noted that the surgeon knowingly used expired product.It was also reported there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.This report is addressing the sterility risk associated with such an event.

• Brand Name: VERTAPLEX HV SINGLE PACK
• Common Device Name: BONE CEMENT, POSTERIOR SCREW AUGMENTATION
• 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: 13446694
• Report Number: 0001811755-2022-00003
• Device Sequence Number: 19909615
• Product Code: PML
• UDI-Device Identifier: 07613327170559
• UDI-Public: 07613327170559
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K192818
• 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): 04/14/2022

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: 0406622015
• Device Catalogue Number: 0406622015
• Device Lot Number: VAB004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2022
• Supplement Date Received by Manufacturer: 03/29/2022
• Initial Report FDA Received Date: 02/03/2022
• Supplement Report FDA Received Date: 04/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown