MAUDE Adverse Event Report: STRYKER SPINE-US ES2 INTEGRATED BLADE SCREW SIZE L 6.5X50MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	482804650
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was not returned.
Event or Problem Description
It was reported that during removal of the screw in s1, the es2 integrated blade screw shaft fractured intra-operatively.The procedure was completed successfully without surgical delay; however, the tip of the screw was left in the patient.
Event or Problem Description
It was reported that during removal of the screw in s1, the es2 integrated blade screw shaft fractured intra-operatively.The procedure was completed successfully without surgical delay; however, the tip of the screw was left in the patient.
Additional Manufacturer Narrative
G1 has been corrected from 'stryker spine-us' to 'stryker spine-france.Visual, dimensional, material and functional analysis could not be performed as the device was not returned.  device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained.It was reported that during removal of the screw, the es2 integrated blade screw shaft fractured intra-operatively.The tip of the screw was left in patient.Due to lack of information and device not returned, an exact cause of the reported event could not be determined.Potential causes include: too much force applied when removing construct may lead to screw fracture and broken fragment remain in patient.H3 other text: device was not returned.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE L 6.5X50MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 11088499
• Report Number: 0009617544-2020-00212
• Device Sequence Number: 1257360
• Product Code: NKB
• UDI-Device Identifier: 07613327002195
• UDI-Public: 07613327002195
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K122845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2021

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: Health Professional
• Device Model Number: 482804650
• Device Catalogue Number: 482804650
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/01/2020
• Supplement Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 12/29/2020
• Supplement Report FDA Received Date: 04/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1