MAUDE Adverse Event Report: STRYKER SPINE-US OASYS POLYAXIAL SCREW NON BIASED DIA 4.5 X 32; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	48558532
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Status and location of the device is unknown.
Event or Problem Description
It was reported that two oasys non biased polyaxial screw tulips disengaged intra-operatively during a scheduled extension.During screw removal, the tulip heads popped off from the screw shanks.The surgeon was able to remove the screw shanks and complete the surgery without harm to the patient.The event did result in a 45 minute surgical delay.This report represents the first of the two screws.
Additional Manufacturer Narrative
Visual, dimensional, functional and material analysis could not be performed as the device was not returned.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.Per oasys surgical technique below: instruments are provided by stryker spine to be used to remove the implants.Any decision by a physician to remove the internal fixation device must take into consideration such factors as the risk to the patient of the additional surgical procedure as well as the difficulty of removal.Removal of an unloosened spinal screw may require the use of special instruments to disrupt the interface at the implant surface.This technique may require practice in the laboratory before being attempted clinically.Implant removal must be followed by adequate postoperative management to avoid fracture or re-fracture.Removal of the implant after fracture healing is recommended.Metallic implants can loosen, bend, fracture, corrode, migrate, cause pain or stress shield bone.Since the device was not returned, an exact cause cannot be determined.However, it is likely that the issue occurred due to over-angulation on screw and application of excessive force.Patient hard bone quality may also have contributed to the event.
Event or Problem Description
It was reported that two oasys non biased polyaxial screw tulips disengaged intra-operatively during a scheduled extension.During screw removal, the tulip heads popped off from the screw shanks.The surgeon was able to remove the screw shanks and complete the surgery without harm to the patient.The event did result in a 45 minute surgical delay.This report represents the first of the two screws.

• Brand Name: OASYS POLYAXIAL SCREW NON BIASED DIA 4.5 X 32
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 10573464
• Report Number: 0009617544-2020-00161
• Device Sequence Number: 3507992
• Product Code: NKG
• UDI-Device Identifier: 04546540596451
• UDI-Public: 04546540596451
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K151755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2020

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: 48558532
• Device Catalogue Number: 48558532
• Device Lot Number: 195128
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/27/2020
• Supplement Date Received by Manufacturer: 11/30/2020
• Initial Report FDA Received Date: 09/23/2020
• Supplement Report FDA Received Date: 12/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1