MAUDE Adverse Event Report: STRYKER SPINE-US OASYS POLYAXIAL SCREW NON BIASED DIA 4.5 X 28; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Model Number 48558528

Device Problems Break (1069); Entrapment of Device (1212); Detachment of Device or Device Component (2907)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 05/24/2018

Event Type  malfunction  

Event Description

During implantation of a screw into the t2 pedicle, the tulip head disengaged.The remaining screw could not be removed and the construct remained in the patient.The surgery had to be terminated at t1 instead of t2 on the right side while the left side was completed successfully.No adverse consequences to the patient were reported.

Manufacturer Narrative

It was reported that while implanting a screw, the tulip head popped off.The device was not returned for evaluation but the reported event was confirmed via communication with the sales rep.The surgical technique warns users to insert the screw with the polyaxial screwdriver by placing the hex head socket over the bone screw and threading the end of the outer sleeve into the polyaxial screw head for stable fixation.The locking screwdriver may also be used and attaches to the screw in the same manner as the standard polyaxial screwdriver.Since the lot number was unknown, no manufacturing records could not be reviewed.Conclusion: the plausible root cause of the reported event could not be determined conclusively.However, according to the risk table the screw could have been misaligned for angular insertion into the bone.

Event Description

During implantation of a screw into the t2 pedicle, the tulip head disengaged.The remaining screw could not be removed and the construct remained in the patient.The surgery had to be terminated at t1 instead of t2 on the right side while the left side was completed successfully.No adverse consequences to the patient were reported.

• Brand Name: OASYS POLYAXIAL SCREW NON BIASED DIA 4.5 X 28
• Type of Device: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• 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: rakshya bista ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 7632693
• MDR Text Key: 112439821
• Report Number: 0009617544-2018-00151
• Device Sequence Number: 1
• Product Code: NKG
• UDI-Device Identifier: 04546540596444
• UDI-Public: (01)04546540596444
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 48558528
• Device Catalogue Number: 48558528
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/31/2018
• 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 Age: 75 YR