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

Catalog Number	48551070
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/04/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a surgery, a part of a connector broke when the surgeon tighten it finally.The surgeon used other one and finished the surgery.
Additional Manufacturer Narrative
Method: device history review; complaint history review; risk assessment.Results: the device was confirmed by the stryker rep to have fractured during surgery resulting in no delay in surgery.Manufacturing records were reviewed and no manufacturing anomalies were reported.Conclusion: the plausible root is not determined and multifactorial due to lack of parts returned.
Event or Problem Description
It was reported that during a surgery, a part of a connector broke when the surgeon tighten it finally.The surgeon used other one and finished the surgery.

• 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: 5532376
• Report Number: 0009617544-2016-00134
• Device Sequence Number: 10841469
• 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
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2016

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 Catalogue Number: 48551070
• Device Lot Number: 7BP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/04/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/29/2016
• Supplement Report FDA Received Date: 06/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR