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

Model Number 482802540

Device Problem Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/04/2021

Event Type  Injury  

Manufacturer Narrative

Surgeon retained implant.

Event 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 third of three screws.

Event 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 third of three screws.

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.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE S 5.5X40MM
• Type of Device: 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: 12392678
• MDR Text Key: 268962867
• Report Number: 0009617544-2021-00144
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07613327001884
• UDI-Public: 07613327001884
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K122845
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 11/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention