MAUDE Adverse Event Report: GENESYS SPINE TILOCK MODULAR SPINAL SYSTEM; SPINAL FIXATION SYSTEM

Model Number SEE EVALUATION SUMMARY

Device Problems Material Deformation (2976); Material Too Soft/Flexible (4007)

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

Event Date 06/26/2019

Event Type  malfunction  

Manufacturer Narrative

The surgeon used the lock screw's threads to reduce the rod as opposed to using any of the rod reducer instrumentation.The surgical technique outlines how to use the modular rod persuader for rod reduction and the system also provides several other rod reduction instruments.However, the surgical technique does not explicitly prohibit the user from performing rod reduction with only the lock screw and the threads of the tulip.Therefore, this will be recorded as a product malfunction.When rod reduction is performed with only the lock screw and the threads of the tulip, the additional force of the lock screw transfers to the tulip thus creating potential for the tulip to splay and the lock screw to potentially cross thread.The lock screw design is very robust in that it can overcome significant misalignment with the pedicle screws and not cross thread.The lock screws have a box thread design which inherently resists cross threading.The modular system tulips have a slimmer design and profile than standard pedicle screw tulips; this was done to facilitate their placement in tighter spaces without requiring significant bone work.During the design process it was not envisioned that the modular system would be used in challenging deformity cases and that rod reduction would be attempted without utilizing the system's reduction instruments.

Event Description

A surgeon was performing a multi-level deformity case using the tilock modular spinal system.Due to rather significant spondylolisthesis, the rod going through a modular xt tulip required a significant amount of reduction.The surgeon attempted to reduce the rod using only the modular lock screw and tulip.He hand-tightened the rod using the setcap starter shaft but when he tried to use the torque limiting t-handle to final tighten, the tulip splayed and allowed the lock screw to cross thread.When the lock screw cross threaded a piece of the thread was shaved off.The shaving and lock screw were then removed.The surgeon attempted to place another modular lock screw in the tulip but during final tightening the tulip again splayed and allowed the lock screw to cross thread.The surgeon removed and replaced the tulip and screw then made a third attempt to place and tighten a lock screw.The third attempt was successful and the procedure was successfully completed.The surgeon took great care to ensure that no metal shavings were left in the patient.The patient is recovering normally with no adverse effects.

• Brand Name: TILOCK MODULAR SPINAL SYSTEM
• Type of Device: SPINAL FIXATION SYSTEM
• Manufacturer (Section D): GENESYS SPINE; 1250 s. capital of tx hwy; bldg 3, ste 600; austin TX 78746
• Manufacturer Contact: andrew davison ; 1250 s. capital of tx hwy; bldg 3, ste 600; austin, TX 78746 ; 5123817071
• MDR Report Key: 8889232
• MDR Text Key: 209804393
• Report Number: 3008455034-2019-00006
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172469
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SEE EVALUATION SUMMARY
• Device Lot Number: SEE EVALUATION SUMMARY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2018
• 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 Outcome(s): Required Intervention
• Patient Age: 56 YR