MAUDE Adverse Event Report: MEDITECH SPINE, LLC. STERILE TALOS-TL (HA) PEEK IBFD; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number 6-220108-00

Device Problems Material Fragmentation (1261); Patient-Device Incompatibility (2682)

Patient Problem Laceration(s) (1946)

Event Date 10/12/2021

Event Type  Injury  

Event Description

Provider dilated l5-s1 vertebral space using two interbody infusion grafts, (talos-tl (ha) peek ibfd manufactured by meditech spine, llc).The first graft was inserted without issue.As the provider was inserting the second graft, it broke into several fragments tearing the thecal sac causing a dural tear which then required surgical repair by the provider.The patient was hospitalized for two days, recovered well and had no further complications.Fda safety report id# (b)(4).

• Brand Name: STERILE TALOS-TL (HA) PEEK IBFD
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MEDITECH SPINE, LLC.; atlanta GA 30309
• MDR Report Key: 12696999
• MDR Text Key: 278598447
• Report Number: MW5104931
• Device Sequence Number: 1
• Product Code: MAX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 6-220108-00
• Device Lot Number: 3772-23-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 42 YR
• Patient Weight: 224