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 Codes	Pain (1994); Spinal Column Injury (2081)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation 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 surgeon completed a t10-ilium posterior lateral fusion on (b)(6) 2016 using the depuy synthes spine expedium spine system (5.5mm), viper cortical fix screws, k2m cascadia tl interbodies from l2-s1, synthes matrix snap on transconnector (at l4-l5) and used vivigen to aid in his effort to fuse.He performed the operation to correct a scoliosis.The patient returned in (b)(6) 2018 to surgeon complaining of pain.Surgeon obtained a ct and xrays to evaluate the patient.He confirmed that the patient had failed to fuse at l4-l5 and broke the cocr rods on both the left and the right of the levels l4-l5.Due to the failed fusion and subsequent breakage of instrumentation, surgeon decided to take the patient back to the operating room to inspect the construct and make the necessary replacements to stabilize the patient for fusion purposes.Surgeon exposed the spine on (b)(6) 2018 in surgery and removed the cocr rods (1967-89-300, x2) as well as the transconnector (04.633.347, x1).He replaced screws at l4, l5, s1 on the right as well as s1/iliac screw on the left.He increased the diameter of those screws to gain sufficient screw purchase.Surgeon removed the screws at t10 and left them out.Surgeon then replaced the rods with titanium expedium rods and new expedium inner set screws.Synthes complaint number for transconnector (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).Visual examination found that the rod was fractured.Device was then sent for fracture analysis.The fracture analysis report exhibits two surface morphologies a smooth and grainy/rough region and progression lines which are indicative of fatigue failure.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.A definitive root cause for the rod fracturing cannot be positively determined.However, the fracture analysis report exhibits two surface morphologies a smooth and grainy/rough region and progression lines which are indicative of fatigue failure.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The problem reported by the customer.

• 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: 7685037
• Report Number: 1526439-2018-50676
• Device Sequence Number: 19161654
• Product Code: NKB
• UDI-Device Identifier: 10705034295251
• UDI-Public: (01)10705034295251
• Combination Product (Y/N): N
• PMA/510(K) Number: K090648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2018

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
• Device Lot Number: GM45387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Initial Date Received by Manufacturer: 06/15/2018
• Supplement Date Received by Manufacturer: 06/15/2018
• Initial Report FDA Received Date: 07/13/2018
• Supplement Report FDA Received Date: 07/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR