MAUDE Adverse Event Report: DEPUY SPINE INC VIPER2 LORDOTIC ROD-55MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 186788055

Device Problem Break (1069)

Patient Problem Spinal Column Injury (2081)

Event Date 01/01/2018

Event Type  Injury  

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 Description

It was reported by a patient's fiance, between 2012 and 2018 patient received spinal fusions from t3 to scrotum with spinal fixation rods from thoracic to scrotum.From her medical records, it was confirmed rods, screws and fusion plate were made by depuy.The rod on the right side has broken twice.She needs to have it repaired.Patient needs an mri and is unsure which material the implants are made from.Patient has reached out to doctor.However, doctor cannot verify material of implants.

• Brand Name: VIPER2 LORDOTIC ROD-55MM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7834000
• MDR Text Key: 118799802
• Report Number: 1526439-2018-50819
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034131764
• UDI-Public: (01)10705034131764
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111136
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 186788055
• Device Catalogue Number: 186788055
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 55 YR