MAUDE Adverse Event Report: STRYKER SPINE-US 9.5X80 POLYAXIAL SCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	482619580
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	03/21/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, the poly-axial pedicle screw tulip head disengaged.It was removed and replace with the same type of screw.All fragment were removed.There was a reported surgical delay of one hour.There are no reports of adverse health consequences to the patient in this event.
Additional Manufacturer Narrative
Method: visual inspection, device history review, complaint history review, risk assessment.Result: the customer reported event was confirmed via visual inspection.The screw was returned in 2 pieces, with the tulip head disengaged from the screw shank.There was deformation on the tulip locking ring and the head of the screw shank.Manufacturing history was reviewed and no issues were identified.Conclusion: the damage seen to the locking ring and the screw shank are indicative to force being applied to the tulip head.Deformation of the locking ring was localized to one area, meaning the tulip head was most likely angulated in that direction when it disengaged.Over angulation and excessive force applied are potential root causes for tulip disengagement.
Event or Problem Description
It was reported that during surgery, the poly-axial pedicle screw tulip head disengaged.It was removed and replace with the same type of screw.All fragment were removed.There was a reported surgical delay of one hour.There are no reports of adverse health consequences to the patient in this event.

• Brand Name: 9.5X80 POLYAXIAL SCREW
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; -; allendale NJ 07401
• MDR Report Key: 7445123
• Report Number: 3005525032-2018-00026
• Device Sequence Number: 1446046
• Product Code: NKB
• UDI-Device Identifier: 07613327352047
• UDI-Public: (01)07613327352047
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2018

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: No Information
• Device Model Number: 482619580
• Device Catalogue Number: 482619580
• Device Lot Number: B73635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2018
• Initial Date Received by Manufacturer: 03/21/2018
• Supplement Date Received by Manufacturer: 05/14/2018
• Initial Report FDA Received Date: 04/19/2018
• Supplement Report FDA Received Date: 06/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR