MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE VUEPOINT II OCT SYSTEM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	8976030P3
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device was returned for evaluation.Photographs of the device were provided and were able to confirm the reported event as the lock screw was found to be installed upside-down.Examination of the photographs identified the lock screw retention clip was applied properly although the screw was upside down, indicating that the root cause of the reported event can be attributed to a packaging issue during the manufacturing process.Corrective action is in process with packaging/manufacturer.No additional investigation is required at this time.Labeling review: "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." ".Packaging: packages for each of the components should be intact upon receipt.Devices should be carefully examined for completeness, and for lack of damage, prior to use.Damaged packages or products should not be used, and should be returned to nuvasive.The instruments and implants of the system may be supplied as either sterile or non-sterile.All implants provided non-sterile are single use and should be sterilized per instructions provided below.Instruments provided non-sterile can be single-use or reusable.Discard single-use instruments after use.Reusable instruments should be reprocessed using instructions provided below.All implants and instruments provided sterile are intended for single use only.Do not use if package is opened or damaged.This product should not be re-sterilized.Discard single-use instruments after use." "handling of the sterile implant, before removing the implants from the package, make sure that the protective packaging is unopened and undamaged.If the packaging is damaged, the implants have to be considered as non-sterile and may not be used.Upon removal from the package, compare the descriptions on the label with the package contents (product number and size).Note the sterile expiry date.Implants with elapsed sterile expiry dates have to be considered as non-sterile.Take particular care that aseptic integrity is assured during removal of the implant from the inner packaging.Open the packages carefully.Take suitable measures to ensure that the implant does not come into contact with objects that could damage its surfaces.Use only the recommended instruments for implantation of the implants.Damaged implants must not be used.".
Event or Problem Description
It was reported that a patient underwent a posterior cervical fusion procedure from c2 to c5.The procedure was planned using bilateral offset connectors; however, an offset connector could not be used on the left c2 side because the lock screw was mounted upside-down and could not be oriented correctly during the procedure.The surgeon opted to change the surgical plan, which included an additional incision made to insert the lock screw at the right side of c2 as the initial screw placement was turned outward.The delay and additional procedural steps contributed to the total operative time being extended by approximately 3 hours.

• Brand Name: NUVASIVE VUEPOINT II OCT SYSTEM
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• 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: patrick yrigoyen ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 19844565
• Report Number: 2031966-2024-00186
• Device Sequence Number: 15102793
• Product Code: NKG
• UDI-Device Identifier: 00887517830340
• UDI-Public: 887517830340
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K180198
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8976030P3
• Device Lot Number: GM005333
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2024
• Initial Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/11/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 84 KG