MAUDE Adverse Event Report: NUVASIVE, INC. VERSATIE PET BAND, 4.5MM HOOK END; BONE FIXATION CERCLAGE, SUBLAMINAR

Model Number 86101245

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 10/26/2022

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to nuvasive for evaluation as it was not removed from the patient and remains in-situ.However, photographs were provided and confirm the reported partial tearing of the band.As no device or further event information was made available, such as operative notes or details on surgical technique, a definitive root cause cannot be determined.However, potential causes/contributors include: excessive tension being applied to the band, an instrument or bone contacting the band creating the damage, or an out-of-spec torque handle being utilized during tightening.Manufacturing review: review of the device history records notes no material non-conformances, no manufacturing errors, and no discrepancies with respect to material type, treatments, or dimensions that may have caused or contributed to this mode of failure.Parts met acceptance criteria upon release.Labeling review: ".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." ".Preoperative warnings: 3.Care should be used in the handling and storage of the versatie implants.The implants should not be scratched or damaged.Implants and instruments should be protected during storage and from corrosive environments.For sterile implants: assure highly aseptic surgical conditions, and use aseptic technique when removing the versatie implant from its packaging.Inspect the implant and packaging for signs of damage, including scratched or damaged devices or damage to the sterile barrier.Do not use the versatie implants if there is any evidence of damage.5.Devices should be inspected for damage prior to implantation.6.Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." ".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.Loss of fixation.Nonunion or delayed union.Pain, discomfort or abnormal sensations due to the presence of the device.".

Event Description

After desired tension of the versatie band was achieved during the final tightening step of the procedure, the surgeon noticed the band was partially torn within the passage window of the clamp.The surgeon opted to keep band and clamp in place.There was no reported adverse patient impact as a result of this event.No additional information is available.

• Brand Name: VERSATIE PET BAND, 4.5MM HOOK END
• Type of Device: BONE FIXATION CERCLAGE, SUBLAMINAR
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd.; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INC.; 7475 lusk blvd.; san diego CA 92121
• Manufacturer Contact: geoffrey gannon ; 7475 lusk blvd.; san diego, CA 92121
• MDR Report Key: 15840605
• MDR Text Key: 307673094
• Report Number: 2031966-2022-00266
• Device Sequence Number: 1
• Product Code: OWI
• UDI-Device Identifier: 00887517984296
• UDI-Public: 887517984296
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161265
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/21/2022

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
• Device Model Number: 86101245
• Device Lot Number: 220062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/28/2022
• Initial Date FDA Received: 11/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2022
• 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 8610260P2, LOT ML02161 (X2)
• Patient Sex: Prefer Not To Disclose