MAUDE Adverse Event Report: NUVASIVE INC. NUVASIVE® COHERE® THORACOLUMBAR INTERBODY SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	1814365
Medical Device Problem Codes	Mechanical Problem (1384); Device Damaged by Another Device (2915); Positioning Problem (3009); Unintended Movement (3026); Activation Problem (4042)
Health Effect - Clinical Code	Unspecified Nervous System Problem (4426)
Date of Event	09/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Rep reported that during a transforaminal lumbar interbody fusion procedure the resident placed the cage without issue but was uncomfortable with the position, so the inserter was reattached, and slap hammered back out.During the stated removal the inserters (1814364 lot ti1718 straight) dowel pin came loose, and it was no longer usable.The cage was then attached to the off-set inserter (1814365 lot ti1580) for placement.During this second impaction of the same cage in-case neural monitoring of the patient (third party cadwell) identified motor deficit had taken place and the approach was aborted, the resident claims that the inserter was allowing the implant to pivot prematurely it became loose and did not engage the interbody fully during implantation.The peek interbody was discarded at the user facility and unavailable for evaluation.
Additional Manufacturer Narrative
The inserter was received by nuvasive although the complaint was not confirmed.The involved interbody was not returned for evaluation.The off set inserter returned and was evaluated under service (b)(4).Where the device was found to be functioning as designed, engagement and articulation functions were confirmed to be within specifications and an implant was firmly attached.No problem was identified or recreated.Review of the reported event and conversation with the attending rep identified the interbody was reused after a unsatisfactory surgeon placement with another inserter requiring excessive malleating damaging the straight inserter and possibly damaging the interbody.Due to the required articulation the peek cohere tlif-a interbody needs to be properly oriented and has an intricate attachment feature that can be susceptible to excessive force and should never be reused as unseen damage may occur during impaction.No definitive root cause can be determined however the inserters full functionality observed and review of the information provided suggests that possible damage to the implant attachment feature during the initial unsatisfactory placement and reuse may have lead to the poor outcome.Additionally implant inserter orientation and articulation challenges from the inserter angulation change (straight to offset) may have been a contributing factor.No additional investigation can be completed.Manufacturing review: review of the device history record notes no material non-conformance, no manufacturing errors, nor discrepancies with respect to material type, treatments, dimensions that may have caused or contributed to this mode of failure.Parts met acceptance criteria upon release.Labeling review: "potential adverse events and complications as with any major surgical procedures, there are risks involved in spinal/orthopedic surgery.Infrequent operative and postoperative complications that may result in the need for additional surgeries include: early or late infection; damage to blood vessels, spinal cord or peripheral nerves." ".Potential risks identified with the use of this system, which may require additional surgery, include.Neurological, vascular or visceral injury.Nerve damage due to surgical trauma, bursitis.Paralysis." "warnings, cautions and precautions the subject device is intended for use only as indicated.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.Correct selection of the implant is extremely important.The potential for success is increased by the selection of the proper size of the implant." ".Notching, striking, and/or scratching of implants with any instrument should be avoided to reduce the risk of breakage.For cohere tlif-a implants, do not position inserter past 90° with respect to the implant.Hyper angulation during impaction may result in implant disengagement." "single use/do not re-use: reuse of a single use device that has come in contact with blood, bone, tissue or other body fluids may lead to patient or user injury.Possible risks associated with reuse of a single use device include, but are not limited to, mechanical failure, material degradation, potential leachable, and transmission of infectious agents." "pre-operative warnings.3.Care should be used in the handling and storage of the cohere 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 cohere 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 cohere implants if there is any evidence of damage.5.Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." "method of use please refer to the surgical technique for this device." "handling of the sterile implant.Damaged implants must not be used." "information to obtain a surgical technique manual or should any information regarding the products or their uses be required, please contact your local representative or nuvasive directly at." 9402772-en k-2022-06.

• Brand Name: NUVASIVE® COHERE® THORACOLUMBAR INTERBODY SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• 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: geoff gannon ; 7475 lusk blvd.; san diego, CA 92121
• MDR Report Key: 17906238
• Report Number: 2031966-2023-00222
• Device Sequence Number: 7467989
• Product Code: MAX
• UDI-Device Identifier: 00887517017581
• UDI-Public: 887517017581
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K200953
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/10/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1814365
• Device Lot Number: TI1580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2023
• 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: 09/15/2023
• Initial Report FDA Received Date: 10/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN COHERE INTERBODY
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Prefer Not To Disclose