MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. ALTERA; ALTERA INSERTER SLEEVE

Model Number 6124.0002

Device Problem Device Slipped (1584)

Patient Problems Cerebrospinal Fluid Leakage (1772); Perforation (2001)

Event Date 04/23/2021

Event Type  Injury  

Manufacturer Narrative

Neither the device nor any imaging were available for evaluation.The cause of the reported puncture is likely traced to unintended user error.

Event Description

It was reported by a representative from the (b)(6) that while impacting a loaded altera inserter with a mallet, the implant slipped, pushing the tip of the inserter fork off the cage and punctured the right side of the patient's dura, causing a dural leak.

• Brand Name: ALTERA
• Type of Device: ALTERA INSERTER SLEEVE
• 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: 12131694
• MDR Text Key: 260432829
• Report Number: 3004142400-2021-00111
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00889095174557
• UDI-Public: 00889095174557
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140411
• 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: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6124.0002
• Device Lot Number: FMW166CC
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/06/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/14/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other