MAUDE Adverse Event Report: DEPUY SYNTHES SPINE MIS TI CFX FEN POLY 6X40; ORTHOSIS, SPINAL PEDICLE FIXATION

Model Number	186727640
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Sudden Cardiac Death (2510)
Date of Event	01/06/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Reporter: (b)(6).During the surgery with viper 2 system, the patient went into the cardiac arrest, followed by the reanimation that was not successful.The patient was an older female, (b)(6), with bechterew disease.The surgery was almost finished at the time of the event, with all the screws inserted and finished vertebroplasty in 6 vertebral bodies.Twelve (12) viper screws/innies, 2 titanium rods, 3 confidence cements.Or doctor provided a medical rationale that indicates the use of the product is in no way related to the reported event: the patient had preexisting medical conditions that could potentially result in the outcome.

• Brand Name: MIS TI CFX FEN POLY 6X40
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount dr.; raynham MA 02767
• MDR Report Key: 7654585
• Report Number: 1526439-2018-50617
• Device Sequence Number: 1064834
• Product Code: MNI
• UDI-Device Identifier: 10705034282558
• UDI-Public: (01)10705034282558
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• PMA/510(K) Number: K160879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/07/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: 186727640
• Device Catalogue Number: 186727640
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2018
• Initial Report FDA Received Date: 07/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death