MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ES2 INTEGRATED BLADE SCREW SIZE L 7.5X40MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 482804740

Device Problems Detachment Of Device Component (1104); Device Dislodged or Dislocated (2923)

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

Event Date 11/14/2017

Event Type  malfunction  

Event Description

It was reported that; screw head popped off during final tightening.The same size screw was used as a replacement with new blockers.

Manufacturer Narrative

Method: risk assessment; result: the reported screw was not returned due to hospital policy, therefore, no device evaluation could be performed.The lot number was not provided, therefore, no complaint history review and device history review could be performed.The cause of event could not be determined.No impact to the patient, no delay and no adverse consequences were reported.

Event Description

It was reported that; screw head popped off during final tightening.The same size screw was used as a replacement with new blockers.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE L 7.5X40MM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: margarita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 7112473
• MDR Text Key: 95078476
• Report Number: 0009617544-2017-00433
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07613327002225
• UDI-Public: (01)07613327002225
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122845
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/13/2018

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: No Information
• Device Model Number: 482804740
• Device Catalogue Number: 482804740
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/14/2017
• Initial Date FDA Received: 12/13/2017
• Supplement Dates Manufacturer Received: 02/26/2018
• Supplement Dates FDA Received: 03/13/2018
• 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