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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SPINE INC VIPER; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
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DEPUY SPINE INC VIPER; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Catalog Number 186788050
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/14/2026
Type of Reportable Event Malfunction
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Brand Name
VIPER
Common Device Name
ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
Manufacturer (Section D)
DEPUY SPINE INC
325 paramount drive
raynham MA 02767
Manufacturer Contact
elba bello
325 paramount drive
raynham, MA 02767
9083863534
MDR Report Key25765501
Report Number1526439-2026-01000
Device Sequence Number9788087
Product Code KWP
UDI-Device Identifier10705034131757
UDI-Public(01)10705034131757
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K111136
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source Health Professional,Company Representative
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
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? Yes
Operator of Device Health Professional
Device Catalogue Number186788050
Device Lot NumberTBACXP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/02/2026
Is the Reporter a Health Professional? Yes
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/08/2026
Initial Report FDA Received Date07/09/2026
Was Device Evaluated by Manufacturer? (Y/N) No
Date Device Manufactured04/21/2020
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
Patient SexUnknown
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