MAUDE Adverse Event Report: DEPUY SPINE INC VIPER2 STRAIGHT ROD300MM, COCR; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	196789300
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that on an unknown date, during spinal fusion, dr.(b)(6) brought the patient back to the operating room for a non-union.Both rods broke at l4, where no screws were placed from the previously implanted construct (t9-ilium).The original t9-ilium construct used expedium cocr rods.When the removal occurred, dr.(b)(6) noticed that the screws bilaterally at l5, s1 and l3 on the right.Dr.(b)(6) decided to remove those screws and replace them by upsizing each screw by 1mm in diameter.There was no surgical delay.Procedure was successfully completed.There was no patient harm/consequence.

• Brand Name: VIPER2 STRAIGHT ROD300MM, COCR
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8625101
• Report Number: 1526439-2019-51665
• Device Sequence Number: 13917794
• Product Code: NKB
• UDI-Device Identifier: 10705034295251
• UDI-Public: (01)10705034295251
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/30/2019

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
• Operator of Device: Health Professional
• Device Model Number: 196789300
• Device Catalogue Number: 196789300
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 05/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention