MAUDE Adverse Event Report: NUVASIVE INC. NUVASIVE RELINE CERVICAL SYSTEM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number 3904530

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 04/28/2023

Event Type  malfunction  

Manufacturer Narrative

The explanted screws were returned to nuvasive for evaluation and the complaint was confirmed.Examination of the two pedicle screws found the damage observed to be consistent with tulip hyperangulation and applied excessive force resulting in prying force separation likely the result of the reported patient postoperative accident.The root cause is considered the result of an inadvertent user error as excessive force applied by the patient accident.No additional investigation required.Labeling review: ".Contraindications: contraindications include, but are not limited to: 4.Patients who are unwilling to restrict activities or follow medical advice." ".Potential adverse events and complications: 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." ".Warnings, caution and precautions: correct selection of the implant is extremely important.The potential for success is increased by the selection of the proper size of the implant.The reline cervical system can also be linked to ø3.5mm¿ ø6.0mm rods of posterior pedicle screw and rod systems via the rod to rod connectors or transition rods.While proper selection can minimize risks, the size and shape of human bones present limitations on the size and strength of the implants.Metallic internal fixation devices cannot withstand the activity levels and/or loads equal to those placed on normal, healthy bone.These devices are not designed to withstand the unsupported stress of full weight or load bearing alone." ".Based on the fatigue testing results, when using the nuvasive reline cervical system, the physician/surgeon should consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc.Which may impact on the performance of the system." ".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." ".Pre-operative warnings: use of cross sectional imaging (i.E., ct and/or mri) for posterior cervical screw placement is recommended due to the unique risks in the cervical spine.The use of planar radiographs alone may not provide the necessary imaging to mitigate the risk of improper screw placement.In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.1.Only patients that meet the criteria described in the indications should be selected.2.Patient condition and/or predispositions such as those addressed in the aforementioned.Contraindications should be avoided." ".Postoperative 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.To ensure the earliest possible detection of such catalysts of device dysfunction, the devices must be checked periodically postoperatively, using appropriate radiographic techniques.".

Event Description

After the initial surgery on unknown date, patient reported accident occurring in her garage while using hammer.Dr.(b)(6) noticed loosened set screws on an x-ray following this accident.At that time, tempel scheduled for a revision that occurred on (b)(6) 2023.During the revision, tempel tested the integrity of the screws with a leksell.With light pressure, the tulip head came off the shank screw.Tempel removed both shanks and replaced with a larger diameter screw.

Event Description

After the initial surgery on unknown date, patient reported accident occurring in her garage while using hammer.Dr.Tempel noticed loosened set screws on an x-ray following this accident.At that time, tempel scheduled for a revision that occurred on (b)(6) 2023.During the revision, tempel tested the integrity of the screws with a leksell.With light pressure, the tulip head came off the shank screw.Tempel removed both shanks and replaced with a larger diameter screw.

Manufacturer Narrative

Corrections made on b5 description of event and d6, updated g6,h2 and b4.

• Brand Name: NUVASIVE RELINE CERVICAL SYSTEM
• Type of Device: POSTERIOR CERVICAL SCREW SYSTEM
• 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: 16931006
• MDR Text Key: 315363716
• Report Number: 2031966-2023-00103
• Device Sequence Number: 1
• Product Code: NKG
• UDI-Device Identifier: 00195377069061
• UDI-Public: 195377069061
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K213654
• 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,Followup
• Report Date: 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3904530
• Device Lot Number: TZ01573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 67 KG