MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFINITY OCCIPITOCERVICAL UPPER THORACIC SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number 3602536

Device Problem Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/12/2020

Event Type  malfunction  

Manufacturer Narrative

Product analysis#: 703805582:3602536, lot# rm18a013.Visual and optical examination identified that the hex of the cone set screw has been stripped.The stripped cone set screw is consistent with over-torque.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider via a manufacturer representative regarding a patient with trauma.It was reported that the lateral set screw stripped as surgeon was attempting to final tighten.The device was replaced, and will be returned.There were no symptoms reported.There were no further complications reported regarding the event.On (b)(6) 2020, (rep) additional information was received from manufacturer representative regarding a patient with occiput to c4 p osterior fusion (levels implanted-occiput to c4) due to trauma.

• Brand Name: INFINITY OCCIPITOCERVICAL UPPER THORACIC SYSTEM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 10539976
• MDR Text Key: 207161920
• Report Number: 1030489-2020-01291
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: 00643169527676
• UDI-Public: 00643169527676
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163375
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3602536
• Device Catalogue Number: 3602536
• Device Lot Number: RM18A013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 10 YR
• Patient Weight: 97