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

Model Number 6124.0002

Device Problem Use of Device Problem (1670)

Patient Problems Hemorrhage/Bleeding (1888); Laceration(s) (1946)

Event Type  Injury  

Event Description

It was reported that during surgery a vein was punctured causing the patient significant blood loss.

Manufacturer Narrative

All four components were returned for evaluation.Initial observation shows the medial tip of the altera inserter sleeve is slightly deformed outward and some wear is visible on the distal tip.This type of damage is seen when the user excessively tightens the gold knob on the altera inserter base.Additional information provided that the case was an l5-s1 tlif with disc prep and mis screws done with robotic navigation.The altera spacer was articulated without issue.When the surgeon attempted to medialize the implant, the implant and inserter assembly shifted through the anterior longitudinal ligament (all) of the l5-s1 disc space.It was reported there was an osteophyte near the disc space on the anterior portion of the l5 vertebra that may have caused or contributed to the all rupturing, which allowed the implant to contact the vein.It was also reported that the implant was not able to be collapsed to remove.This is likely due to pulling on the inserter, as this causes the spring in the threaded shaft to compress and disengage the driver shaft.After removing the implant, it was noted that there were pieces of a mesh stent inside the altera implant, and the patient started to bleed significantly.It is possible that the osteophyte could have compromised the integrity of the all allowing the event to occur; however, an exact cause to the reported issue could not be determined.

• Brand Name: ALTERA ARTICULATING EXPANDABLE TLIF
• Type of Device: ALTERA INSERTER SLEEVE
• 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: 14498442
• MDR Text Key: 292724088
• Report Number: 3004142400-2022-00075
• 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: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2022
• 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: FMX021KC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2022
• Date Manufacturer Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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