MAUDE Adverse Event Report: DEPUY SPINE INC VIPER2 STRAIGHT ROD-600MM, COC; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	196789600
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Unspecified Infection (1930); Spinal Column Injury (2081)
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
Further to (b)(4), on (b)(6) 2018, when the patient visited the hospital due to a lower back pain, the breakage of the rod (196789600) was found under the x-ray between l4 and l5 (right), and between l5 and s (left).On (b)(6) 2018, the re-operation was rescheduled due to the patient¿s high crp (c-reactive protein) level.On (b)(6) 2018, the re-operation was performed to find the cause of the patient¿s high crp (c-reactive protein) level, considering the suspected infections.The procedures were conducted in the following way.- screws at l4, l5 and s1 (right) were extracted and new screws were inserted at l5 and s1 to connect with upper rods using a connector.- a screw at l5 (left) was extracted to connect with upper rods using a connector.- si set screws at l4 and over (both sides) were replaced with new ones, and rods at far end were also replaced with new ones.Also, the following were commented by the surgeon.- loosening of all the screws were observed when extracted - torque was not properly applied to si set screws when extracted.- black-colored substances were seen around the screw and the rod, which might have been caused by the metal corrosion.- the patient¿s crp level might have increased due to armd caused by the metal corrosion.
Additional Manufacturer Narrative
(b)(4).The rod was found to be broken at its lengthwise midpoint and was subsequently submitted for fracture analysis.Optical imaging of the fracture shows a smooth region and a grainy/rough region with progression lines, which are indicative of fatigue failure.No material defects or other abnormalities were observed in this analysis.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.The root cause of the rod breaking postoperatively cannot be determined from the sample and information provided.The results of fracture analysis have determined that a potential root cause may be 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.

• Brand Name: VIPER2 STRAIGHT ROD-600MM, COC
• 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: 7736313
• Report Number: 1526439-2018-50723
• Device Sequence Number: 805563
• Product Code: NKB
• UDI-Device Identifier: 10705034295282
• UDI-Public: (01)10705034295282
• 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: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2018

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: 196789600
• Device Catalogue Number: 196789600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2018
• Initial Date Received by Manufacturer: 07/02/2018
• Supplement Date Received by Manufacturer: 08/23/2018
• Initial Report FDA Received Date: 07/31/2018
• Supplement Report FDA Received Date: 08/24/2018
• 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