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

Catalog Number	0406622000
Medical Device Problem Code	Expiration Date Error (2528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting return of device to manufacturer.
Event or Problem Description
It was reported that prior to a surgical procedure and upon receipt, the cement product was observed to be expired.It was also reported that this event did not occur during a surgical procedure, and there was no delay or adverse consequences as a result of this event.
Additional Manufacturer Narrative
Correction from reportable event to non reportable event; the reported event, for expired cement, was not confirmed as following a review of the device history information versus the reported event date of this event the product had not expired at the time of use.No product malfunction was observed following a review of manufacturing expiry information and event details reported in this case.The cement was not expired at the time of use.Based on the information provided, there is no report of adverse consequences, patient involvement or a significant delay in this event.There is no report of adverse consequences or a significant delay in this event and no previous reports of injury on file as a result of similar events.Having reviewed the risk documentation, there is no information to suggest that a recurrence would result in injury.There is no evidence at this time to suggest filing is necessary.If further information becomes available, this will be re-assessed.H3 other text : device discarded by customer.
Event or Problem Description
It was reported that prior to a surgical procedure and upon receipt, the cement product was observed to be expired.It was also reported that this event did not occur during a surgical procedure, and there was no delay or adverse consequences as a result of this event.Update (b)(6) 2023; following a review of the device history information versus the reported event date of this event the product had not expired at the time of use.No product malfunction was observed following a review of manufacturing expiry information and event details reported in this case.The cement was not expired at the time of use.Based on the information provided, there is no report of adverse consequences, patient involvement or a significant delay in this event.

• Brand Name: VERTAPLEX HV GLOBAL TWIN PK
• 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: 15218505
• Report Number: 0001811755-2022-00031
• Device Sequence Number: 20515655
• Product Code: PML
• UDI-Device Identifier: 37613252254431
• UDI-Public: 37613252254431
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 02/24/2023

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 Catalogue Number: 0406622000
• Device Lot Number: VKA067
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/14/2022
• Supplement Date Received by Manufacturer: 02/24/2023
• Initial Report FDA Received Date: 08/12/2022
• Supplement Report FDA Received Date: 02/24/2023
• 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