MAUDE Adverse Event Report: STRYKER SPINE-US ES2 INTEGRATED BLADE SCREW SIZE L 7.5X90MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	482804790
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the head of the reported es2 integrated blade screw had come off at l5.The patient was revised to remove the reported screw and replace the construct.
Additional Manufacturer Narrative
B5 updated to include event occurred approximately one week post-operatively.Visual inspection was performed and found the tulip to be disengaged from the screw shank.Locking ring on base of tulip is deformed.Locking ring deformation indicates the tulip was highly angled with respect to the shank head.There is additional deformation on the edge of the screw shank bulb which indicates that the rod was placed with a high degree of angulation in the tulip head and was not seated properly in the tulip.Returned blockers were inspected.Two blockers appear to have been tightened properly onto properly placed rods.One blocker appears to have been under tightened, as there are no rod deformation marks on the under side.One blocker appears to have been placed on a rod that was highly angled in the tulip head, as there is rod deformation on one side but not the other.There was no allegation of failure of the returned blockers which all functioned as intended and were determined to be concomitant.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.The es2 surgical technique guide was reviewed: caution: extra caution is advised in the following cases: the rod is not horizontally placed into the screw head.The rod is high in the screw head.An acute convex or concave bend is contoured into the rod.Final tightening of the construct.Once the necessary correction procedures have been performed and the spine is fixed in a satisfactory position, the final tightening of the blockers is performed using the counter torque tube and the torque wrench or audible torque wrench.The surgical technique guide states that extra caution should be advised when the rod is not horizontally placed into screw head.The most likely cause of the reported event was determined to be the over angulation of the rod placement in the tulip head.
Event or Problem Description
It was reported that the head of the reported es2 integrated blade screw had come off at l5, approximately one week post-operatively.The patient was revised to remove the reported screw and replace the construct.This record captures the tulip disengagement of the es2 integrated blade screw.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE L 7.5X90MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 12442311
• Report Number: 0009617544-2021-00147
• Device Sequence Number: 17116412
• Product Code: NKB
• UDI-Device Identifier: 07613327002423
• UDI-Public: 07613327002423
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2021

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
• Operator of Device: Health Professional
• Device Model Number: 482804790
• Device Catalogue Number: 482804790
• Device Lot Number: 181085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/10/2021
• Supplement Date Received by Manufacturer: 11/24/2021
• Initial Report FDA Received Date: 09/08/2021
• Supplement Report FDA Received Date: 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown