MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ES2 INTEGRATED BLADE SCREW SIZE S 6.5X45MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number 482802645

Device Problems Break (1069); Detachment Of Device Component (1104); No Apparent Adverse Event (3189)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 06/08/2015

Event Type  Injury  

Event Description

When breaking the tabs on the short blade 6.5/45mm screws, one of the tabs broke off above the reduction thread at the weld joint.This incident wasn't noticed until the patient went in for a post op office visit.When the doctor ordered a post op x-ray he noticed the thread part of the tab still attached.The patient will be brought back to have the tab removed.

Manufacturer Narrative

Method: device not returned; results: manufacturing records could not be reviewed because no lot number was reported (device remains implanted).Based on the event during the breaking the tabs on the es2 system short blade, one of the tabs broke off above the reduction thread at the weld joint.Conclusion: the surgical technique outlines how to break off the tabs during surgery including using imaging so the likely root cause is deviation from instructions.

Event Description

When breaking the tabs on the short blade 6.5/45mm screws, one of the tabs broke off above the reduction thread at the weld joint.This incident wasn't noticed until the patient went in for a post op office visit.When the doctor ordered a post op x-ray he noticed the thread part of the tab still attached.The patient will be brought back to have the tab removed.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE S 6.5X45MM
• 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: linford leitch ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 4926376
• MDR Text Key: 6430067
• Report Number: 0009617544-2015-00335
• Device Sequence Number: 1
• Product Code: NKB
• 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: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/25/2015

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: Other
• Device Catalogue Number: 482802645
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/25/2015
• Initial Date FDA Received: 07/20/2015
• 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
• Patient Outcome(s): Required Intervention