MAUDE Adverse Event Report: DEPUY SYNTHES SPINE VIPER 2 SCREW; UNKNOWN VIPER SCREW

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Pain (1994); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

This report is being filed after the subsequent review of the following literature article: wang, q.Y., huang, m.G., ou, d.Q., xu, y.C., dong, j.W., yin, h.D.,.& rong, l.M.(2017).One-stage extreme lateral interbody fusion and percutaneous pedicle screw fixation in lumbar spine tuberculosis.Journal of musculoskeletal & neuronal interactions, 17(1), 450.N= 1 post-op loosening.

• Brand Name: VIPER 2 SCREW
• Type of Device: UNKNOWN VIPER SCREW
• 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: 6568272
• MDR Text Key: 75209113
• Report Number: 1526439-2017-10363
• Device Sequence Number: 1
• Product Code: MRW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/18/2017
• 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