MAUDE Adverse Event Report: STRYKER SPINE-US ES2 INTEGRATED BLADE SCREW SIZE L 4.5X35MM; PEDICLE SCREW SPINAL SYSTEM.

Catalog Number	482804435
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/02/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, the screw did not be attached to the driver smoothly.The reduction thread of the screw seemed to be deformed.
Additional Manufacturer Narrative
Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment; results: manufacturing records were reviewed and no anomalies were found.The submitted blade screw was functionally tested and found to accept a blocker without jamming.Conclusion: the reported event could not be confirmed and no product issue was found.
Event or Problem Description
It was reported that during surgery, the screw did not be attached to the driver smoothly.The reduction thread of the screw seemed to be deformed.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE L 4.5X35MM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM.
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 5458130
• Report Number: 0009617544-2016-00076
• Device Sequence Number: 357026
• Product Code: NKB
• UDI-Device Identifier: 07613327002300
• UDI-Public: 07613327002300
• Combination Product (Y/N): N
• PMA/510(K) Number: K122845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2016

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: No Information
• Device Catalogue Number: 482804435
• Device Lot Number: 140021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/02/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/24/2016
• Supplement Report FDA Received Date: 06/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR