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

Model Number 488515030

Device Problems Detachment Of Device Component (1104); Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/06/2018

Event Type  malfunction  

Event 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 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.

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
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7311380
• MDR Text Key: 101613980
• Report Number: 0009617544-2018-00059
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07613327134148
• UDI-Public: (01)07613327134148
• Combination Product (y/n): N
• PMA/PMN Number: K152632
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 02/06/2018
• Initial Date FDA Received: 03/02/2018
• Supplement Dates Manufacturer Received: 05/24/2018
• Supplement Dates FDA Received: 05/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR