MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ES2 INTEGRATED BLADE SCREW SIZE S 7.5X50MM; PEDICLE SCREW SPINAL SYSTEM.

Model Number 482802750

Device Problems Detachment Of Device Component (1104); Mechanical Problem (1384); Connection Problem (2900)

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

Event Date 04/04/2017

Event Type  malfunction  

Event Description

It was reported that "lumbale artrodese l5-s1, spondylolisthese.Toggle after final fixation s1 screw on the right.Preparing to distraction to get open neuroforames and to achieve reduction of the listhesis.Tubes placed on the sleeves.Connected to each other to make distraction possible.At that time, before the distraction, the toggle screw s1 was detected on the right.Several checks with x-ray to see if the screw would not sit properly, but nothing pointed in that direction.Distraction carried out, again x-ray.Visible that tulip was not connected to the screw.Disassembly, screw extraction.New screw taken (one that was 5mm longer, same diameter).New assembly, distraction performed again and after cage placement, bilateral compression.Reduction of listhesis also performed.".

Manufacturer Narrative

Method: visual inspection; device history review; complaint history review; risk assessment.Results: no relevant manufacturing issues were identified as all units met stryker specifications.The screw was inspected and the tulip head was disengaged from the main thread body.Conclusion: it is likely that due to the patient's hard bone quality (sclerotic), an excessive force was applied during the insertion of the screw and the tulip may have disengaged upon distraction due to deformed locking clip.

Event Description

It was reported that "lumbale artrodese l5-s1, spondylolistheses.Toggle after final fixation s1 screw on the right.Preparing to distraction to get open neuroforamen and to achieve reduction of the listhesis.Tubes placed on the sleeves.Connected to each other to make distraction possible.At that time, before the distraction, the toggle screw s1 was detected on the right.Several checks with x-ray to see if the screw would not sit properly, but nothing pointed in that direction.Distraction carried out, again x-ray.Visible that tulip was not connected to the screw.Disassembly, screw extraction.New screw taken (one that was 5mm longer, same diameter).New assembly, distraction performed again and after cage placement, bilateral compression.Reduction of listhesis also performed.".

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE S 7.5X50MM
• 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: 6530427
• MDR Text Key: 74167877
• Report Number: 0009617544-2017-00181
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07613327002027
• UDI-Public: (01)07613327002027
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 07/17/2017

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: 482802750
• Device Catalogue Number: 482802750
• Device Lot Number: 16C688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2017
• Initial Date FDA Received: 04/28/2017
• Supplement Dates Manufacturer Received: 04/04/2017
• Supplement Dates FDA Received: 07/17/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/28/2016
• 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 Age: 73 YR