MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ES2 INTEGRATED BLADE SCREW SIZE S 6.5X40MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number 482802640

Device Problem Detachment Of Device Component (1104)

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

Event Date 10/27/2015

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2015, the patient underwent the surgery with es2.The surgeon used the blade remover, in order to remove blade.After surgery, when the surgeon checked the x-ray, it turned out that the part of blade remained in screw head.Therefore, the surgeon opened patient's wound again, used the blade remover, and removed the part of blade on (b)(6) /2015.

Manufacturer Narrative

Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment; results: insufficient engagement of the blade in the blade remover results in unintentional loading outside of the proximity of the integrated blade break line.Conclusion: the most likely cause of the reported fracture is insufficient engagement of the blade in the blade remover.

Event Description

It was reported that on (b)(6) 2015, the patient underwent the surgery.The surgeon used the blade remover, in order to remove blade.After surgery, when the surgeon checked the x-ray, it turned out that the part of blade remained in screw head.Therefore, the surgeon opened patient's wound again, used the blade remover, and removed the part of blade on (b)(6) 2015.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE S 6.5X40MM
• Type of Device: PEDICLE SCREW SPINAL 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: christa marrow ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 5243491
• MDR Text Key: 31936882
• Report Number: 0009617544-2015-00490
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K122845
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 482802640
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2015
• Initial Date FDA Received: 11/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/07/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR