MAUDE Adverse Event Report: PRECISION SPINE, INC NEXGEN ANTERIOR CERVICAL PLATE SYSTEM; SCREW

Model Number	65-DF-4016
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a procedure on (b)(6) 2024 utilizing the slimplicity hp anterior cervical plate system.Subsequently, a revision procedure was performed on (b)(6) 2025 to address screw backout.The two 4.0mm x 16mm self drilling fixed screw slimplicity hp (65-df-4016) located at the bottom of the plate have started to back out.It was also noted upon going in, that the bottom locking mechanism on the plate assembly 2-level 30mm slimplicity hp (65-ca-2030) was broken/unattached.
Additional Manufacturer Narrative
H3 other - evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be submitted.
Additional Manufacturer Narrative
H3 device evaluation - evaluation by engineering noted the following.Upon review of the x-rays and placing the fixed screws in these holes at prescribed and over angulated orientation it appears that the two fixed screws were angulated more than 10°.The screw head was below the plate surface when properly oriented and seats proud when over angulated.Based upon the wear on the underside of the rivet and wear on the upper outer edge of the screw it is believed that the screw placement in this instance may have resulted in a preloading condition on the rivet that led to low cycle fatigue failure of the rivet.Soft tissue or other factors may have hindered proper instrument placement leading to the angulation observed.Review of device history records found (b)(4) pieces of this released for distribution on 5/16/2024 with no deviation or anomalies.Two-year complaint history review (12.18.2023-12.18.2025) found this to be the only report for this part number.No corrective actions are being recommended.
Event or Problem Description
It was reported that the patient inderwent a procedure on (b)(6) 2024, utilizing the slimplicity hp anterior cervical plate system.Subsequently, a revision procedure was performed on (b)(6) 2025, to address screw backout.The two 4.0mm x 16mm self drilling fixed screw slimplicity hp (65-df-4016) located at the bottom of the plate have started to back out.It was also noted upon going in, that the bottom locking mechanism on the plate assembly 2-level 30mm slimplicity hp (65-ca-2030) was broken/unattached.

• Brand Name: NEXGEN ANTERIOR CERVICAL PLATE SYSTEM
• Common Device Name: SCREW
• Manufacturer (Section D): PRECISION SPINE, INC; 2050 executive drive; pearl MS 39208
• Manufacturer (Section G): PRECISION SPINE, INC; 2050 executive drive; pearl MS 39208
• Manufacturer Contact: mike dawson ; 2050 executive drive; pearl, MS 39208 ; 6014204244
• MDR Report Key: 24073075
• Report Number: 3005739886-2026-00010
• Device Sequence Number: 18486908
• Product Code: KWQ
• UDI-Device Identifier: 00840019932790
• UDI-Public: (01)00840019932790(11)240410(10)48042PS
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K192494
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2025

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: 65-DF-4016
• Device Catalogue Number: 65-DF-4016
• Device Lot Number: 48042PS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/18/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2024
• 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 Sex: Unknown