MAUDE Adverse Event Report: STRYKER SPINE-US ES2 INTEGRATED BLADE SCREW SIZE S 7.5X40MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	482802740
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 3 weeks following the initial surgery, an es2 integrated blade screw and mantis straight rod fractured post-operatively.Revision surgery has been performed.This record represents the blade screw.
Additional Manufacturer Narrative
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.There is also a sharp angulation midway through the shank bulb indentation, indicating that rod tightening was performed at least twice at tulip head/rod over angulation and tulip head/rod severe over angulations.It was stated bone fusion was not achieved.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.It is unknown what torque the blockers were tightened to, the surgical technique states they must be tightened to 12nm and anti torque must be used.It is unknown if anti torque was used.Based on the deformation found on the returned screw, the most likely cause is multi factorial.Possible causes for tulip disengagement include overtightening of the blocker, fractured rod causing an unstable construct, excessive rod angulation and/or excessive post op activity.
Event or Problem Description
It was reported that approximately 3 weeks following the initial surgery, an es2 integrated blade screw and mantis straight rod fractured post-operatively.Revision surgery has been performed.This record represents the blade screw.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE S 7.5X40MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 11069519
• Report Number: 0009617544-2020-00210
• Device Sequence Number: 19648353
• Product Code: NKB
• UDI-Device Identifier: 07613327002003
• UDI-Public: 07613327002003
• 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 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): 04/22/2021

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: 482802740
• Device Catalogue Number: 482802740
• Device Lot Number: 17C096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Initial Date Received by Manufacturer: 03/30/2021
• Supplement Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 12/23/2020
• Supplement Report FDA Received Date: 04/22/2021
• 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