MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE VERSATIE SYSTEM; BONE FIXATION CERCLAGE, SUBLAMINAR

Model Number 86101245

Device Problem Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/15/2022

Event Type  Injury  

Manufacturer Narrative

No device was returned to nuvasive for evaluation; the reported event was confirmed by review of photographs of the explanted band.No operative notes and/or radiograph images were provided for review of usage/technique.A review of the device history record was performed and no discrepancies relevant to the reported event were found.A definitive root cause was unable to be determined with the information provided.Labeling review: ".Potential adverse events and complications: potential risks identified with the use of this system, which may require additional surgery, include: disassembly, fraying, kinking, loosening, bending or breakage of any or all of the versatie system implant components." ".Warnings, cautions and precautions: the implantation of the spinal system should be performed only by experienced spinal surgeons with specific training in the use of this spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.These devices are not designed to withstand the unsupported stress of full weight or load bearing alone.Additional fixation is required at the cephalad and caudal ends of the construct in scoliosis surgery, especially in case of obesity, extreme kyphosis or muscular weakness, except where additional fixation would increase the risk to the patient." ".Patient selection: proper patient selection is critical to the success of the procedure.Only patients who satisfy the criteria set forth under the indications section of this document and who do not have any of the conditions set forth under the contraindications section of this document should be considered for spinal fixation surgery using the nuvasive versatie system." if any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

Event Description

It was reported that the patient underwent an initial three (3) level posterior fixation procedure from l4 to s2 using rod fixation and two (2) sublaminar fixation bands placed bilaterally on the cranial side of l4.Subsequently, the patient underwent a revision procedure approximately four (4) months later due to a compression fracture at l3, adjacent to the existing fixation construct, and kyphosis.During the revision procedure, the bands were identified to have ruptured on both sides.The revision was completed using rod-to-rod connectors and extension of the fixation construct to l3/l4 and l2/l3.It was noted the patient had weak bone quality, however there were no reports of falls or other trauma.No further patient impact was reported.No additional information was available.Report 1 of 2.

• Brand Name: NUVASIVE VERSATIE SYSTEM
• Type of Device: BONE FIXATION CERCLAGE, SUBLAMINAR
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 15965882
• MDR Text Key: 305341550
• Report Number: 2031966-2022-00279
• Device Sequence Number: 1
• Product Code: OWI
• UDI-Device Identifier: 00887517984296
• UDI-Public: 887517984296
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K161265
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 86101245
• Device Catalogue Number: N/A
• Device Lot Number: 210810
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: VERSATIE CLAMP, PN 8610260
• Patient Outcome(s): Hospitalization
• Patient Age: 83 YR
• Patient Sex: Female