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

Model Number 186789480

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Type  Injury  

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 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 2 of 2 for (b)(4).

• Brand Name: VIPER2 STRAIGHT ROD-480MM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): BRIDGEWATER DISTRIBUTION; 50 scotland boulevard; bridgewater MA 02324
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 10792749
• MDR Text Key: 214798286
• Report Number: 1526439-2020-02097
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034133522
• UDI-Public: (01)10705034133522
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K111136
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 186789480
• Device Catalogue Number: 186789480
• Device Lot Number: TBYPV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNKNOWN LOCKING/SET SCREWS; UNKNOWN SCREWS; VIPER2 STRAIGHT ROD-480MM
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR