MAUDE Adverse Event Report: STRYKER SPINE-US ES2 INTEGRATED BLADE SCREW SIZE L 7.5X60MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	482804760
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Injury (2348); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Return status of the device is unknown.
Event or Problem Description
It was reported that three es2 integrated blade screw tulips at l4 left/right and l3 left disengaged post-operatively.The patient was implanted with es2 screws on (b)(6) 2020.The patient was then revised on (b)(6) 2020, where the screws were explanted and replaced.This report captures the l3 left side screw.
Event or Problem Description
It was reported that three es2 integrated blade screw tulips at l4 left/right and l3 left disengaged post-operatively.The patient was implanted with es2 screws on (b)(6) 2020.The patient was then revised on (b)(6) 2020, where the screws were explanted and replaced.This report captures the l3 left side screw.
Additional Manufacturer Narrative
The customer reported event of a es2 integrated blade screw tulip disengagement post-op was confirmed via visual inspection and provided x rays.Visual inspection: the screw was returned with the tulip disengaged from the screw shank.The tulip locking ring was deformed.The shank bulb had a deep and angled rod indentation, indicative of tulip angulation and overtightening.Device and complaint history records were reviewed for the corresponding lot and no relevant manufacturing issues or similar complaints were identified.As the disengagement was discovered on the day of the surgery, the screws most likely disengaged during the initial surgery.The x ray provided, indicated one screw was disengaged.The compromised construct likely caused additional stress on other screws, causing them to disengage as well.It cannot be determined which of the three screws returned was the first to disengage.It is unknown what torque the blockers were tightened to or if anti-torque was used, however, the surgical technique states they must be tightened to 12nm and anti torque must be used.Based on the deformation found on the returned screw, the most likely cause is overtightening of the blocker causing the tulip to disengage.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE L 7.5X60MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 10489619
• Report Number: 0009617544-2020-00152
• Device Sequence Number: 16848010
• Product Code: NKB
• UDI-Device Identifier: 07613327002393
• UDI-Public: 07613327002393
• Combination Product (Y/N): N
• PMA/510(K) Number: K122845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2020

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: 482804760
• Device Catalogue Number: 482804760
• Device Lot Number: 146902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Initial Date Received by Manufacturer: 08/06/2020
• Supplement Date Received by Manufacturer: 10/31/2020
• Initial Report FDA Received Date: 09/03/2020
• Supplement Report FDA Received Date: 11/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention