MAUDE Adverse Event Report: STRYKER SPINE-US POLYAXIAL CORTICAL SCREW 5.0 X 30; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	488515030
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/06/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an l4-l5 fusion, all screws had been successfully implanted.The surgeon then took the parallel posts and post distractor to distract and perform tlif.He threaded the post onto the l4 screw and began to tighten post onto screw, and the tulip head on the screw disengaged.A screwdriver was then used to remove shaft of screw and a new screw was reinserted.Surgeon distracted off contra-lateral screws and locked a rod in place to complete discectomy and tlif.The procedure was successfully completed and there were no adverse consequences to the patient.
Event or Problem Description
It was reported that during an l4-l5 fusion, all screws had been successfully implanted.The surgeon then took the parallel posts and post distractor to distract and perform tlif.He threaded the post onto the l4 screw and began to tighten post onto screw, and the tulip head on the screw disengaged.A screwdriver was then used to remove shaft of screw and a new screw was reinserted.Surgeon distracted off contra-lateral screws and locked a rod in place to complete discectomy and tlif.The procedure was successfully completed and there were no adverse consequences to the patient.
Additional Manufacturer Narrative
Method: visual inspection, product history review, complaint history review, risk assessment.Result: the customer reported event was confirmed via visual inspection.The screw was returned in 2 pieces as the tulip head was disengaged from the screw.There was deformation on the bottom of the tulip head as well as the head of the screw shank.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Visible damage on the bottom of the tulip head and on the head of the screw shank, suggests that the tulip was forcibly disengaged.As it was reported that the surgeon did not get any resistance from the post as he attached to the screw, it is possible the distractor was not fully engaged with the tulip, which could have caused it to disengage when force was applied to it when distracted.

• Brand Name: POLYAXIAL CORTICAL SCREW 5.0 X 30
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7311380
• Report Number: 0009617544-2018-00059
• Device Sequence Number: 14031337
• Product Code: NKB
• UDI-Device Identifier: 07613327134148
• UDI-Public: (01)07613327134148
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K152632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2018

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 Model Number: 488515030
• Device Catalogue Number: 488515030
• Device Lot Number: 167676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Initial Date Received by Manufacturer: 02/06/2018
• Supplement Date Received by Manufacturer: 05/24/2018
• Initial Report FDA Received Date: 03/02/2018
• Supplement Report FDA Received Date: 05/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR