MAUDE Adverse Event Report: DEPUY SPINE INC VIPER2 STRAIGHT ROD-480MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	186789480
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional procodes: kwp, kwq, mnh, mni, osh.A review of the receiving inspection (ri) for viper2 straight rod, ti (480mm) was conducted identifying that lot number tbypv was released in a single batch.Batch 1: released on april 15, 2019 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.(b)(4).Device was used for treatment, not diagnosis.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
Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2019, the patient underwent a procedure in the lumbar spine to treat tuberculous spondylitis.On an unknown postoperative date, it was found that two rods had broken off.Patient underwent revision surgery on (b)(6) 2020.Complications with this revision procedure were reported under (b)(4).This report is for a viper2 straight rod-480mm.This is report 1 of 2 for (b)(4).

• Brand Name: VIPER2 STRAIGHT ROD-480MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10792662
• Report Number: 1526439-2020-02096
• Device Sequence Number: 3645858
• Product Code: NKB
• UDI-Device Identifier: 10705034133522
• UDI-Public: (01)10705034133522
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111136
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/09/2020

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: 186789480
• Device Catalogue Number: 186789480
• Device Lot Number: TBYPV
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/09/2020
• Initial Report FDA Received Date: 11/05/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN LOCKING/SET SCREWS; UNKNOWN SCREWS; VIPER2 STRAIGHT ROD-480MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR