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U.S. Department of Health and Human Services

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

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DEPUY SYNTHES SPINE VIPER 2 SCREW; UNKNOWN VIPER SCREW Back to Search Results
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.
 
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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 Key6568272
MDR Text Key75209113
Report Number1526439-2017-10363
Device Sequence Number1
Product Code MRW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/18/2017
Initial Date FDA Received05/15/2017
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 Number1
Patient Outcome(s) Other; Required Intervention;
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