MAUDE Adverse Event Report: STRYKER SPINE-US ES2 INTEGRATED BLADE SCREW SIZE L 6.5X60MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	482804660
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted.
Event or Problem Description
A physician reported a post-operative fracture of an es2 integrated blade screw placed on the right side at s1.Revision surgery is not planned and there has been no adverse consequence to the patient.
Event or Problem Description
A physician reported a post-operative fracture of an es2 integrated blade screw placed on the right side at s1.Revision surgery is not planned and there has been no adverse consequence to the patient.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device history and complaint history records were reviewed for the provided lot number and no relevant manufacturing issues or similar complaints were identified.From es2 surgical technique: 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.No complication during initial surgery was reported, patient did not experience a fall and performed normal activity level.Patient's bone quality is unknown.Based on available information, an exact root cause could not be determined but may have occurred due to following: instable construct; overtightened blocker; incorrect screw trajectory; poor bone quality/patient pathology.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE L 6.5X60MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 9079499
• Report Number: 0009617544-2019-00111
• Device Sequence Number: 16705334
• Product Code: NKB
• UDI-Device Identifier: 07613327002362
• UDI-Public: 07613327002362
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K122845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2019

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 Catalogue Number: 482804660
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/20/2019
• Supplement Date Received by Manufacturer: 10/31/2019
• Initial Report FDA Received Date: 09/17/2019
• Supplement Report FDA Received Date: 11/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR