MAUDE Adverse Event Report: OSSEUS FUSION SYSTEMS BLACK DIAMOND PEDICLE SCREW SYSTEM; TORQUE LIMITING DRIVER

Catalog Number 1010-1024

Device Problems Improper or Incorrect Procedure or Method (2017); Measurement System Incompatibility (2982)

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

Event Date 09/06/2017

Event Type  malfunction  

Manufacturer Narrative

While performing tlif procedure surgeon initially reported difficulty using 100 in-lb torque limiter, and reported that he felt it was not properly limiting at specified torque values.Upon return to manufacturer, surgeon's reports were verified by test values.Additional information was later received from the sales representative on august 6th, 2018 indicating that the surgeon fractured the patient's pedicle during the final tightening process.Additionally, it was further stated that proper surgical technique was not followed, and that the surgeon felt the use of a counter torque would have been restrictive and was not used.Based on a multitude of factors it cannot be determined if the adverse outcome of this surgery was due to the instrument which was found to be slightly out of specification, improper surgical technique, or a combination of these two factors.Submission of a medical device report and the fda's release of that information is not an admission that a product, user facility, importer, distributor, manufacturer, or medical personnel caused or contributed to the event.

Event Description

While performing tlif procedure surgeon initially reported difficulty using 100 in-lb torque limiter, and reported that he felt it was not properly limiting at specified torque values.

• Brand Name: BLACK DIAMOND PEDICLE SCREW SYSTEM
• Type of Device: TORQUE LIMITING DRIVER
• Manufacturer (Section D): OSSEUS FUSION SYSTEMS; 2703 w. mockingbird ln.; dallas TX 75235
• Manufacturer (Section G): OSSEUS FUSION SYSTEMS; 2703 w. mockingbird ln.; dallas TX 75235
• Manufacturer Contact: jonathan rosen ; 2703 w. mockingbird ln.; dallas, TX 75235 ; 4074975263
• MDR Report Key: 7795945
• MDR Text Key: 117851089
• Report Number: 3010531060-2018-00002
• Device Sequence Number: 1
• Product Code: MNI
• UDI-Device Identifier: B0622000161306L0
• UDI-Public: +B0622000161306L0/$
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131810
• 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: 08/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1010-1024
• Device Lot Number: 1111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2017
• Date Manufacturer Received: 08/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2017
• 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 Outcome(s): Required Intervention
• Patient Age: 59 YR