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

Model Number	482802750
Medical Device Problem Codes	Detachment Of Device Component (1104); Mechanical Problem (1384)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	04/04/2017
Type of Reportable Event	Malfunction
Event or Problem 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.".
Additional 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 or Problem 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
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6530427
• Report Number: 0009617544-2017-00181
• Device Sequence Number: 1202127
• Product Code: NKB
• UDI-Device Identifier: 07613327002027
• UDI-Public: (01)07613327002027
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K122845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 04/04/2017
• Supplement Date Received by Manufacturer: 04/04/2017
• Initial Report FDA Received Date: 04/28/2017
• Supplement Report FDA Received Date: 07/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR