MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. PROVIDENCE; SPINAL FIXATION PLATE, NON-BIOABSORBABLE

Model Number	150.354
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The providence plate was not returned for evaluation.The eef states that the construct had screws pull-through the plate.The representative was contacted for additional information.The rep provided a do and an xray from the 6-month checkup, the middle 4 screws have clearly "pulled through".The construct also included a coalition agx integrated spacer on the superior-most disc space.Upon reviewing the do it was made clear that providence screws were not used for all of the providence screw holes (only 5 providence screws on the do).The xray shows that they were only used for the superior-most and inferior-most screw holes.The rest of the screws used in the construct were from the universal acdf caddie, which cannot be used in place of providence bone screws because the universal acdf screws have a smaller head size, and this is an off-label use.They did not interfere with the plate and thus "pulled through".Using universal acdf screws in place of providence bone screws is off label, therefore the risk reconciliation portion of this document was not completed.In the products lifetime, there has been 1 complaint associated with the surgeons using the incorrect screws with a providence plate (or complaints classified as a screw pull through).The ifu states "the providence¿ anterior cervical plate system consists of plates used with either variable or fixed angle screws.The plate attaches to the anterior portion of the vertebral body of the cervical spine (levels c2-c7).The implants of this system are manufactured from titanium alloy." this verbiage states that (providence) plates are to be used with (providence) variable or fixed angle screws.This evaluation determined that this failure was due to off-label use.Therefore, no further actions will be taken at this time.If further information is provided, this complaint can be reopened in the future.
Event or Problem Description
It was reported that screws went through the providence plate.The patient came back for 6-month checkup after surgery and complained of pain.After the images came back the doctor noticed that some of the screws on the plate had gone through.

• Brand Name: PROVIDENCE
• Common Device Name: SPINAL FIXATION PLATE, NON-BIOABSORBABLE
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer (Section G): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer Contact: daniel paul ; 2560 general armistead avenue; audubon, PA 19403 ; 6109301800
• MDR Report Key: 24865921
• Report Number: 3004142400-2026-00070
• Device Sequence Number: 16089350
• Product Code: KWQ
• UDI-Device Identifier: 00849044003659
• UDI-Public: 00849044003659
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K070775
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/13/2026

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: 150.354
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 04/13/2026
• 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: Other
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Race: White