MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO AUTOPLEX SYSTEM W/ VERTAPLEX W/O NEEDLES; BONE CEMENT

Catalog Number 0605687000

Device Problem Disassembly (1168)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/30/2014

Event Type  malfunction  

Event Description

It was reported that during a kyphoplasty the delivery tube snapped at the distal tip of the autoplex system.The procedure was completed successfully utilizing back-up equipment.No clinically significant delay, no medical intervention and no adverse consequences were reported with this event.

Manufacturer Narrative

The device will not be returned as it was discarded by the user facility; it is not possible to determine the cause of the reported malfunction without an evaluation of the device.

• Brand Name: AUTOPLEX SYSTEM W/ VERTAPLEX W/O NEEDLES
• Type of Device: BONE CEMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 0061 5
• Manufacturer (Section G): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 0061 5
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 3823264
• MDR Text Key: 15361869
• Report Number: 0001811755-2014-01844
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072118
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0605687000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/30/2014
• 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