MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. PROVIDENCE; PROVIDENCE ANTERIOR CERVICAL PLATE 3-LEVEL, 45MM US

Model Number 150.345

Device Problem Device Slipped (1584)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/28/2021

Event Type  malfunction  

Manufacturer Narrative

The device was not available for evaluation as it was discarded by the hospital.Imaging provided shows the screw to have backed out of the plate past the blocking mechanism.The exact cause of the reported issue could not be determined.

Event Description

It was reported that a revision surgery was completed due to screws backing out of a providence plate 8 months post operatively.

• Brand Name: PROVIDENCE
• Type of Device: PROVIDENCE ANTERIOR CERVICAL PLATE 3-LEVEL, 45MM US
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• Manufacturer (Section G): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• Manufacturer Contact: daniel paul ; 2560 general armistead avenue; audubon 19403 ; 6109301800
• MDR Report Key: 12483030
• MDR Text Key: 272891266
• Report Number: 3004142400-2021-00189
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 00849044003628
• UDI-Public: 00849044003628
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070775
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 150.345
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/18/2021
• Was Device Evaluated by Manufacturer?: No
• 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 Outcome(s): Other