MAUDE Adverse Event Report: HD LIFESCIENCES LLC TLIF HIVE-T INTERBODY SPACER; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT

Model Number	03-A-0006-4010
Date of Event	09/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: review of device history records found devices met all acceptance criteria.Review of device usage found no issues with devices from the same lot or other lot numbers.Bench testing of a similar device identified the failure condition only when exposed to excessive torque force.Devices of this size are not to be inserted and rotated per system labeling and training.
Event or Problem Description
It was reported that the device broke into two pieces during an attempt to rotate the device into position in the disc space.The proximal piece of the device was completely removed.The distal piece of the device was reported to be in the desired position in the disc space and was left in the patient at the surgeon's discretion.Resulted in no delay in surgery and no reports of adverse consequences to the patient.

• Brand Name: TLIF HIVE-T INTERBODY SPACER
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT
• Manufacturer (Section D): HD LIFESCIENCES LLC; 12 gill st; ste 4500; woburn MA 01801
• MDR Report Key: 9247999
• Report Number: 3013462427-2019-00001
• Device Sequence Number: 1410458
• Product Code: MAX
• UDI-Device Identifier: 00817493020824
• UDI-Public: 00817493020824
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K170676
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/25/2019

1 Device was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/16/2024
• Device Model Number: 03-A-0006-4010
• Device Catalogue Number: 03-A-0006-4010
• Device Lot Number: 116307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 10/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes