MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; HEAD REMOVAL TOOL

Model Number 6134.1005

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/24/2021

Event Type  malfunction  

Manufacturer Narrative

Neither the device nor any imaging was available for evaluation.No determinations could be made as to the cause of the reported issue.

Event Description

It was reported by a representative in (b)(6) that the instrument broke, and the broken piece remains in the patient.A revision surgery is planned.

Manufacturer Narrative

The fractured tip of the device was not available as it remains in the patient.Inspection of the device shows a small section of the distal tip to have fractured.The exact cause of the reported issue could not be determined.

Event Description

It was reported by a representative in japan that the instrument broke, and the broken piece remains in the patient.A revision surgery is planned.

• Brand Name: CREO
• Type of Device: HEAD REMOVAL TOOL
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• MDR Report Key: 11765457
• MDR Text Key: 250966039
• Report Number: 3004142400-2021-00083
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00889095178388
• UDI-Public: 00889095178388
• Combination Product (y/n): N
• PMA/PMN Number: D154976
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6134.1005
• Device Lot Number: HAX022DE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2021
• Initial Date Manufacturer Received: 04/06/2021
• Initial Date FDA Received: 05/03/2021
• Supplement Dates Manufacturer Received: 04/06/2021
• Supplement Dates FDA Received: 05/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR