MAUDE Adverse Event Report: STRYKER SPINE-US ES2 INTEGRATED BLADE SCREW SIZE S 5.5X40MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	482802540
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Surgeon retained implant.
Event or Problem Description
It was reported that three es2 integrated blade screws migrated post-operatively at t12, l2 and l3.The patient was revised to remove the migrated screws.This record captures the first of three screws.
Additional Manufacturer Narrative
The device was not returned so an evaluation could not be performed.Manufacturing records and complaint history could not be reviewed as lot# was not provided.Complaint history was reviewed for the corresponding catalog number, and no adverse trends were observed.Per additional correspondence with the field representative, the patient did not experience an external trauma post initial surgery.Operative notes and x-rays were not provided.It is unknown how the bone was prepared and how the screw was inserted during initial surgery.Patient's bone quality is unknown.Due to lack of information, an exact cause of the reported event could not be determined.Potential causes include: poor bone quality of patient, patient experiences external trauma/ performs high intensity post-op activity, instable construct and inadequate bone preparation during the initial surgery.
Event or Problem Description
It was reported that three es2 integrated blade screws migrated post-operatively at t12, l2 and l3.The patient was revised to remove the migrated screws.This record captures the first of three screws.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE S 5.5X40MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 12392674
• Report Number: 0009617544-2021-00145
• Device Sequence Number: 11663109
• Product Code: NKB
• UDI-Device Identifier: 07613327001884
• UDI-Public: 07613327001884
• 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: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2021

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: 482802540
• Device Catalogue Number: 482802540
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/04/2021
• Supplement Date Received by Manufacturer: 11/19/2021
• Initial Report FDA Received Date: 08/31/2021
• Supplement Report FDA Received Date: 12/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown