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

Catalog Number 0406622000

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 05/11/2017

Event Type  malfunction  

Manufacturer Narrative

Device discarded.

Event Description

It was reported that during preparation for the procedure that the monomer vial broke.No medical intervention and no adverse consequences were reported with this event.As this event occurred prior to the procedure, there was no patient involvement and no delay.

• Brand Name: VERTAPLEX HV GLOBAL TWIN PK
• Type of Device: 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
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 6621515
• MDR Text Key: 76964636
• Report Number: 0001811755-2017-01297
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/08/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: 0406622000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/11/2017
• Initial Date FDA Received: 06/08/2017
• 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