MAUDE Adverse Event Report: DEPUY SYNTHES SPINE VIPER2 X-TAB POLY SCREW; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Device Problem Malposition of Device (2616)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

Udi: unknown product information not provided.Two (2) cases revision misplaced screw reported in literature article.No product failure indicted.Depuy spine reports all non-planned revisions as mdr events, regardless of manufacturer of devices being removed.No patient specific identifiers provided.Three requests for additional information sent to author and no response returned.One medwatch will be sent for two cases.This complaint was generated from literature review for health authority reporting purposes.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the pms 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.Sample not available.

Event Description

This report is being filed after the subsequent review of the following literature article: keric et al: evaluation of surgical strategy of conventional vs.Percutaneous robot-assisted spinal trans-pedicular instrumentation in spondylodiscitis.Received: 6 february 2016 / accepted: 26 april 2016.N=2 revision misplaced screw.N=4 revision loosened screw.N=7 wound infection.N=4 surgical wound revision.

• Brand Name: VIPER2 X-TAB POLY SCREW
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808201
• MDR Report Key: 6129332
• MDR Text Key: 60941479
• Report Number: 1526439-2016-10884
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 11/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention