MAUDE Adverse Event Report: DEPUY SYNTHES SPINE VIPER2 STRAIGHT ROD-300MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 186789300

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Sudden Cardiac Death (2510)

Event Date 01/06/2018

Event Type  Death  

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 Description

(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.The 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: VIPER2 STRAIGHT ROD-300MM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount dr.; raynham MA 02767
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: jason busch ; 325 paramount dr.; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7655491
• MDR Text Key: 112918381
• Report Number: 1526439-2018-50630
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034133164
• UDI-Public: (01)10705034133164
• Combination Product (y/n): N
• Reporter Country Code: ES
• PMA/PMN Number: K071860
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 186789300
• Device Catalogue Number: 186789300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death