MAUDE Adverse Event Report: STRYKER SPINE-US ES2 INTEGRATED BLADE SCREW SIZE S 6.5X55MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	482802655
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/29/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient presented with pain, x-ray confirmed the breakage of an es2 integrated screw at l3 right.During revision surgery on (b)(6) 2019, the proximal end of the broken screw was removed, however, the distal end of the screw could not be explanted and remains in the vertebra l3 level.A new screw was implanted and the construct was extended by one level.
Additional Manufacturer Narrative
Visual inspection confirmed fractured screw at threading/main body.Fractured tip was not returned as it remains implanted in the patient.Device and complaint history records were reviewed, no relevant manufacturing issues or similar complaints were identified.No complication during initial surgery was reported, patient did not experience any fall/ trauma.Patient is 66 years old male, weighs 110kg with height 190cm.From es2 augmentable ifu: while the expected life of spinal implant components is difficult to estimate, it is finite.These components are made of foreign materials which are placed within the body for the potential fusion of the spine and reduction of pain.However, due to the many biological, mechanical and physicochemical factors which affect these devices but cannot be evaluated in vivo, the components cannot be expected to indefinitely withstand the activity level and loads of normal healthy bone.An overweight or obese patient can produce loads on the spine which can lead to failure of the fixation of the device or to failure of the device itself.Based on available information, root cause of reported event is most likely excess load placed on construct due to patient obesity.
Event or Problem Description
It was reported that patient presented with pain, x-ray confirmed the breakage of an es2 integrated screw at l3 right.During revision surgery on (b)(6) 2019, the proximal end of the broken screw was removed, however, the distal end of the screw could not be explanted and remains in the vertebra l3 level.A new screw was implanted and the construct was extended by one level.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE S 6.5X55MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8977793
• Report Number: 0009617544-2019-00109
• Device Sequence Number: 16212185
• Product Code: NKB
• UDI-Device Identifier: 07613327001969
• UDI-Public: 07613327001969
• Combination Product (Y/N): N
• PMA/510(K) Number: K122845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2019

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 Catalogue Number: 482802655
• Device Lot Number: 173648
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/12/2019
• Supplement Date Received by Manufacturer: 10/29/2019
• Initial Report FDA Received Date: 09/09/2019
• Supplement Report FDA Received Date: 11/26/2019
• 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
• Patient Age: 66 YR
• Patient Weight: 110