MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG INFINITY OCCIPITOCERVICAL UPPER THORACIC SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number G3600315

Device Problem Material Deformation (2976)

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

Event Date 09/25/2020

Event Type  malfunction  

Manufacturer Narrative

Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional via a field contact regarding a patient with a pre-operative diagnosis of dislocation fracture at c3/c4, undergoing a spinal therapy.It was reported that, even though the counter torque was pushed in firmly at the time of final tightening, idling occurred.After that, the same event occurred even though the driver shaft was changed.The set screw stripped at final tightening.In the 8 units of set screws in total, stripping occurred from the second to third one, all the set screws after that stripped without being able to apply the torque properly.After the stripping at the beginning, even though the driver was changed the situation was not improved.Counter torque was used as if mas rod pusher counter torque, the driver was rotated and the method inserting into set screw had been performed properly.The set screw was implanted in a tightened state until just before torque was applied.The doctor commented that he thinks the set screw was applied to the torque in the right direction, but it stripped.There was a delay in the procedure of less than 60 mins.There were no patient symptoms/complications reported.The set screw remains in patient and the driver will be returned.Levels implanted: c2-c5 additional information received.6 set screws have stripped in total, all of the same lot.At final tightening after the force was slowly applied and the driver was rotated, it idled with a crack sound while the torque limiting handle should idle with a click sound usually.The final tightening was unable to be performed because of this driver issue.Therapy details: dislocation fracture c2-5lms it was reported that only the drivers will be returned.

• Brand Name: INFINITY OCCIPITOCERVICAL UPPER THORACIC SYSTEM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer (Section G): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer Contact: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 10740897
• MDR Text Key: 213220628
• Report Number: 1030489-2020-01494
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K163375
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G3600315
• Device Catalogue Number: G3600315
• Device Lot Number: H5546293
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2020
• Date Device Manufactured: 07/21/2019
• 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