MAUDE Adverse Event Report: STRYKER SPINE-US OASYS TRANSVERSE CONNECTOR; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Model Number	48551070
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/09/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the transverse connector was final tightened, it was broken.The connector was replaced with a new one and the operation was continued.There are no reports of adverse health consequences to the patient.
Event or Problem Description
It was reported that when the transverse connector was final tightened, it was broken.The connector was replaced with a new one and the operation was continued.There are no reports of adverse health consequences to the patient.
Additional Manufacturer Narrative
Method: visual inspection, functional inspection, product history review, complaint history review, labelling review, risk assessment conclusion: the event was confirmed upon visual inspection of the returned device, the connector is fractured as reported.Manufacturing records were reviewed and no manufacturing anomalies were identified.No similar complaints were identified for the reported lot number.Materials analysis was performed on a similar device with the same failure mode and found that the device fractured in ductile overload.The elemental composition of the connector met what was specified on the drawing.No material or manufacturing defects were found.The plausible root cause of the reported event is most likely multifactorial.Contributing factors to device fracture: too much torsional force applied during tightening, previous damage to the clip during insertion.

• Brand Name: OASYS TRANSVERSE CONNECTOR
• Common Device Name: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7474971
• Report Number: 0009617544-2018-00096
• Device Sequence Number: 16537862
• Product Code: NKG
• UDI-Device Identifier: 04546540371607
• UDI-Public: (01)04546540371607
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2018

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: 48551070
• Device Catalogue Number: 48551070
• Device Lot Number: NJR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2018
• Initial Date Received by Manufacturer: 04/09/2018
• Supplement Date Received by Manufacturer: 06/28/2018
• Initial Report FDA Received Date: 05/01/2018
• Supplement Report FDA Received Date: 07/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR