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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NUVASIVE, INCORPORATED NUVASIVE RELINE SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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NUVASIVE, INCORPORATED NUVASIVE RELINE SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 13550000
Device Problems Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907)
Patient Problem Pain (1994)
Event Date 05/13/2022
Event Type  malfunction  
Manufacturer Narrative
No product was returned for evaluation but a radiograph provided was able to confirm the alleged complaint. No torque handle information could be provided and it is unknown if the surgeon utilized hand tightening. The patients post op activity levels or whether a fall was experienced is unknown. The root cause of the lock screw expulsion is unknown however cross threading, rod normalization or insufficient torque are suspected as possible root causes. No additional investigation can be completed at this time. Label review: ". Potential adverse events and complications - as with any major surgical procedures, there are risks involved in orthopedic surgery. Infrequent operative and postoperative complications that may result in the need for additional surgeries. Potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s), loss of fixation. " ". All lock screws should be final-tightened with the counter-torque and torque t-handle. Do not final-tighten through compression instruments (e. G. C/d rack and figure 8 compressor) in the set, as the rod may not be able to normalize to the tulip. " ". All implants should be used only with the appropriately designated instrument (reference surgical technique)¿" ". Patient education: preoperative instructions to the patient are essential. The patient should be made aware of the limitations of the implant and potential risks of the surgery. The patient should be instructed to limit postoperative activity, as this will reduce the risk of bent, broken or loose implant components. The patient must be made aware that implant components may bend, break or loosen even though restrictions in activity are followed. " ". Post-operative warnings - during the postoperative phase it is of particular importance that the physician keeps the patient well informed of all procedures and treatments. Damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration, as well as to other complications. ".
 
Event Description
It was reported that the patient underwent an initial one (1) level posterior fixation procedure at l4/5 using an anterior tlif interbody cage and posterior fixation. Subsequently, on an unknown date, the patient reported symptoms of pain. Upon examination, it was identified that the lock screw was found to be loose and the interbody cage had migrated laterally and was outside of the disc space. The patient underwent a revision procedure approximately ten (10) weeks after the initial surgery to remove the expulsed lock screw and migrated device and extend the fixation construct from l3 to s2. No further patient impact was reported.
 
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Brand NameNUVASIVE RELINE SYSTEM
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
NUVASIVE, INCORPORATED
7475 lusk boulevard
san diego CA 92121
Manufacturer (Section G)
NUVASIVE, INCORPORATED
7475 lusk boulevard
san diego CA 92121
Manufacturer Contact
geoff gannon
7475 lusk boulevard
san diego, CA 92121
MDR Report Key14648629
MDR Text Key301496096
Report Number2031966-2022-00112
Device Sequence Number1
Product Code NKB
UDI-Device Identifier00887517551702
UDI-Public887517551702
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K182974
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number13550000
Device Lot NumberN307264
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received08/24/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/24/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/09/2022 Patient Sequence Number: 1
Treatment
11355040 ROD LOT CT151913; 13550000 LOCK SCREW LOT N303916; 16027545 MAS RED SCREW LOT JP23980; COROENT ANT TLIF PEEK PN 5191304P2
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