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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/06/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from healthcare professional via field representative regarding patient with symptoms of opll (ossification of the posterior longitudinal ligament) involved in posterior cervical decompression and fusion procedure.Levels implanted: c2-t3.It was reported that intra-operatively, three out of the 16 set screws were stripped.It was put out a feeler to replace the set screws, but the set screws were stripped and couldn't be removed, so they were continued to be placed.Product was used correctly according to the directions given in the ifu/labeling.Event was associated with patient.There were no patient symptoms or complications reported as a result of this event.There was delay in overall procedure time for less than 60minutes.No health damage in the patient was reported.On 2021-may-11, received additional information that, when the set screw placed on the screw was finally tightened, it stripped, and no torque was applied.It was attempted to remove all three stripped products by turning them in the opposite direction, but they could not be removed and continued to be implanted.After stripping occurred, the driver was replaced, but the event was the same.The counter had been used (mas).On 2021-may-12, received additional information that product came in contact with the patient.On 2021-may-12, received additional information that screwdriver did not cause stripping of screw, it was operated in accordance with surgical technique and the set screw stripped.The driver was not broken.It was tried to remove the set screws about twice but set screws didn't come off.On 2021-may-24, received additional information that two if torque limiting drivers were found to be stripped at tips.Both could mate with a sample set screw.On 2021-may-26, received additional information that there was no reoperation planned/scheduled.

• 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: 11913694
• MDR Text Key: 268064050
• Report Number: 1030489-2021-00725
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2021
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2021
• 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: 45 YR