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

Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Osteomyelitis (4533)
Date of Event	08/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2021, th3/4/5/6/10/11/12 were fixed with reline due to infectious spondylitis.On (b)(6) 2021 a patient underwent a spinal procedure at t3/6 and t10/12 due to infectious spondylitis.On (b)(6) 2022 a revision surgery was conducted due to recurrence of infection and loosening of the pedicle screws on the left side.The rods were cut on the caudal side of th6.A pedicle screw was added to the left th2, and the pedicle screws of th4, 5, and 6 were increased in size.A 2-hole inline connector was installed in th6 and connected to the rod on the caudal side.The rod on the right side was cut on the caudal side of th6.A pedicle screw was added to th2 and the pedicle screw of th4 was increased in size.The pedicle screws of th5 and th6 were not removed.A 2-hole inline connector was placed on the caudal side of th6 and connected to the rod on the caudal side.The screw head of the 2-hole inline connector on the right side was not stripped.The patient's bone quality was in very poor condition.
Additional Manufacturer Narrative
No product was returned and no images or lab tests were provided therefore the complaint cannot be confirmed.Patient reportedly had poor bone quality.Review of the complaint report identified the index procedure and the revision were conducted due to osteomyelitis and indicate a continuation of patient pathology and considered the root cause of the reported screw loosening.No additional investigation can be completed.Products used: 10055325 reline-o x-conn, 25mm 5.5 rod fixed, n231429; 12355500 reline mas ti rod, 5.5x500mm straight, ct145725; 13114535 reline-o screw, 4.5x35mm traction poly, sa5035; 13114535 reline-o screw, 4.5x35mm traction poly, sa5035; 13550000 reline lock screw, 5.5mm open tulip, n302361; 16024530 reline mas red screw, 4.5x30mm poly 2c, jp15530; 16024530 reline mas red screw, 4.5x30mm poly 2c, jp21599; 16024530 reline mas red screw, 4.5x30mm poly 2c, tz00029; 16024530 reline mas red screw, 4.5x30mm poly 2c, tz00794r; 16026540 reline mas red screw, 6.5x40mm poly 2c, n298123; 16027540 reline mas red screw, 7.5x40mm poly 2c, jp18116; 16027540 reline mas red screw, 7.5x40mm poly 2c, n297828; 16027540 reline mas red screw, 7.5x40mm poly 2c, n300398; 16027540 reline mas red screw, 7.5x40mm poly 2c, tz00318.Labeling review: ".Contraindications: contraindications include, but are not limited to: patients with inadequate bone stock or quality.Patients with physical or medical conditions that would prohibit beneficial surgical outcome." ".Potential adverse events and complications: infrequent operative and postoperative complications that may result in the need for additional surgeries include: early or late infection; as with any major surgical procedures, there are risks involved in orthopedic surgery.Bending, fracture or loosening of implant components, loss of fixation, infection." ".Warnings, cautions and precautions: the implantation of spinal systems 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." ".Pre-operative warnings: only patients that meet the criteria described in the indications should be selected.Patient condition and or predispositions such as those addressed in the aforementioned contraindications should be avoided.Care should be used in the handling and storage of the reline 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 reline 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 reline implants if there is any evidence of damage." ".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." ".Cleaning and decontamination: all non-sterile instruments must first be thoroughly cleaned using the validated methods prescribed in the nuvasive cleaning and sterilization instructions doc 9400896 before sterilization and introduction into a sterile surgical field.Contaminated instruments should be wiped clean of visible soil at the point of use, prior to transfer to a central processing unit for cleaning and sterilization.The validated cleaning methods include both manual and automated cleaning.Visually inspect the instruments following performance of the cleaning instructions to ensure there is no visual contamination of the instruments prior to proceeding with sterilization.If possible contamination is present at visual inspection, repeat the cleaning steps.Contaminated instruments should not be used, and should be returned to nuvasive.Contact your local representative or nuvasive directly for any additional information related to cleaning of nuvasive surgical instruments.Instruments with a d prefix part number may be disassembled.Please refer to the additional disassembly instructions for these instruments." ".Sterilization: all non-sterile instruments and implants are sterilizable by steam autoclave using standard hospital practices, in addition to nuvasive¿s validated parameters.In a properly functioning and calibrated steam sterilizer, effective sterilization may be achieved using the parameters prescribed in the nuvasive cleaning and sterilization instructions doc 9400896.".

• Brand Name: NUVASIVE RELINE SYSTEM
• Common Device Name: THORACOLUMBOSACRAL 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 Key: 15351852
• Report Number: 2031966-2022-00176
• Device Sequence Number: 5863270
• Product Code: NKB
• UDI-Device Identifier: 00887517555885
• UDI-Public: 887517555885
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K182974
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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): 09/02/2022

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
• 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: 08/09/2022
• Initial Report FDA Received Date: 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male