MAUDE Adverse Event Report: NUVASIVE NUVASIVE RELINE SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

No product has been returned for investigation.Based on the information provided no root cause can be identified.

Event Description

Received information stating physician had experienced locking caps becoming loose.It is unknown if this caused any revision procedures.Multiple attempts were made to try and retrieve further event and patient information.

• Brand Name: NUVASIVE RELINE SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: yobana sanchez ; 7475 lusk boulevard; san diego 92121 ; 8589093383
• MDR Report Key: 9438691
• MDR Text Key: 183098421
• Report Number: 2031966-2019-00261
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K190636
• 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: 11/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/11/2019
• Initial Date FDA Received: 12/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1