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

Model Number	2110-0039
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/20/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the connector was broken while tightening the interconnection during rod placement stage.A spare implant was used to complete the surgery.There are no reports of adverse consequences to the patient.
Additional Manufacturer Narrative
The reported event was confirmed via visual inspection of the returned device.The connector clip was found fractured.The material analysis was performed on the similar device with the same failure mode a fracture surface was found to have fractured in ductile overload.The elemental composition of the device met what was specified on the drawing.Conclusion: a root cause of the event is excessive tightening torque applied and/or previous damage to the clip during insertion.
Event or Problem Description
It was reported that the connector was broken while tightening the interconnection during rod placement stage.A spare implant was used to complete the surgery.There are no reports of adverse consequences to the patient.

• Brand Name: OASYS TRANSVERSE CONNECTOR
• Common Device Name: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 7244231
• Report Number: 0009617544-2018-00032
• Device Sequence Number: 140465
• Product Code: NKG
• UDI-Device Identifier: 00808232001372
• UDI-Public: (01)00808232001372
• Combination Product (Y/N): N
• PMA/510(K) Number: K151755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2018

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: Health Professional
• Device Model Number: 2110-0039
• Device Catalogue Number: 48551070
• Device Lot Number: 7BN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2018
• Initial Date Received by Manufacturer: 01/10/2018
• Supplement Date Received by Manufacturer: 03/19/2018
• Initial Report FDA Received Date: 02/06/2018
• Supplement Report FDA Received Date: 04/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1