MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS TRANSVERSE CONNECTOR; SPINAL INTERLAMINAL FIXATION ORTHOSIS.

Model Number	48551070
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/17/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the transverse connector was broken during final tightening and they were removed from the patient.The surgeon changed it with the new one and the surgery succeeded.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment.Results: manufacturing records were reviewed and no manufacturing anomalies were reported.Connector was confirmed visually to have fractured.Conclusion: the plausible root causes include: excessive tightening torque applied and previous damage to the clip during insertion.
Event or Problem Description
It was reported that the transverse connector was broken during final tightening and they were removed from the patient.The surgeon changed it with the new one and the surgery succeeded.

• Brand Name: OASYS TRANSVERSE CONNECTOR
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6485502
• Report Number: 0009617544-2017-00144
• Device Sequence Number: 1268408
• Product Code: KWP
• UDI-Device Identifier: 04546540371607
• UDI-Public: (01)04546540371607
• Combination Product (Y/N): N
• PMA/510(K) Number: K032394
• 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): 07/05/2017

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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2017
• Initial Date Received by Manufacturer: 03/17/2017
• Supplement Date Received by Manufacturer: 03/17/2017
• Initial Report FDA Received Date: 04/12/2017
• Supplement Report FDA Received Date: 07/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR