MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ES2 INTEGRATED BLADE SCREW SIZE S 8.5X40MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number 482802840

Device Problems Device Issue (2379); Malposition of Device (2616)

Patient Problems Pain (1994); Injury (2348)

Event Date 01/12/2016

Event Type  Injury  

Event Description

It was reported that the patient underwent plif for l4/5/s on (b)(6) 2015.On (b)(6), the patient complaint pain.The surgeon noticed that s1 screw contacted to s1 nerve root and the root cause of pain is the contact.So, revision surgery was performed on same day.S1 screw was removed and new screw was implanted.

Manufacturer Narrative

Method: risk assessment.Results: the reported complaint was confirmed by the stryker rep.Manufacturing records could not be reviewed because the explanted devices were discarded and the lot numbers were not provided.Conclusion: the plausible root cause of the reported event is driving the screw too far into the vertebral body as advised against in the stg.

Event Description

It was reported that the patient underwent plif for l4/5/s on (b)(6) 2015.On (b)(6), the patient complaint pain.The surgeon noticed that s1 screw contacted to s1 nerve root and the root cause of pain is the contact.So, revision surgery was performed on same day.S1 screw was removed and new screw was implanted.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE S 8.5X40MM
• 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 NJ 33610 ; FR 33610
• Manufacturer Contact: rakshya bista ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 5413744
• MDR Text Key: 37574417
• Report Number: 0009617544-2016-00047
• 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: 01/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 482802840
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2016
• 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
• Patient Age: 60 YR