MAUDE Adverse Event Report: WARSAW ORTHOPEDICS ATLAS CABLE SYSTEM; WIRE, SURGICAL

Catalog Number	826-213
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/21/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.
Event or Problem Description
It was reported that on (b)(6) 2016, patient presented with pre-op diagnosis: odontoid fracture, atlanto-axial dislocation.For which patient underwent, posterior cervical reduction, internal fixation surgery.Intra-op, at the end of the surgery, the cable had breakage after the physician fixed and cut the cable.The physician had to use steel wire reinforcement to complete the surgery successfully.The product was implanted in the patient.No patient complications were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: ATLAS CABLE SYSTEM
• Common Device Name: WIRE, SURGICAL
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 6259332
• Report Number: 1030489-2017-00123
• Device Sequence Number: 10886796
• Product Code: LRN
• UDI-Device Identifier: 00673978047980
• UDI-Public: 00673978047980
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K892651
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2016

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: Health Professional
• Device Expiration Date: 10/12/2023
• Device Catalogue Number: 826-213
• Device Lot Number: 0427628W
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/23/2016
• Supplement Date Received by Manufacturer: 12/23/2016
• Initial Report FDA Received Date: 01/18/2017
• Supplement Report FDA Received Date: 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR