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

Model Number	03-A-0005-4007
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/07/2018
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 force.It is being concluded that the use of an insert and rotate technique exposed the device to an excessive torque force.Note: electronic submission delayed due to esg access issues.
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 two pieces were completely removed and a device of the same size was used in its place.There are no reports of adverse consequences to the patient.Less than 15 minute delay in surgery.

• Brand Name: TLIF HIVE-T INTERBODY SPACER
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT
• Manufacturer (Section D): HD LIFESCIENCES; 12 gill st; suite 4500; woburn MA 01801
• MDR Report Key: 7897501
• Report Number: 3013462427-2018-00001
• Device Sequence Number: 1394542
• Product Code: MAX
• UDI-Device Identifier: 00817493020190
• UDI-Public: (01)00817493020190(17)221109(10)106021
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K170676
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/07/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/09/2022
• Device Model Number: 03-A-0005-4007
• Device Catalogue Number: 03-A-0005-4007
• Device Lot Number: 106021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2018
• Initial Report FDA Received Date: 09/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR