MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO, MED REL 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 02/19/2021

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.The following products were also used in the surgery.Product id: 3606201 (screwdriver 3606201 torque limit shaft) lot# kh19e676; quantity:2.Product id: g851100 (handle g851100 torque limiting t) lot# 119130; quantity: 1.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 c5 tumor, undergoing a c2-th1 fixation procedure for a spinal therapy.It was reported that the screw stripped when the set screw was finally tightened.Stripping occurred at two places, so using of torque wrench was given up and the surgeon decided to use manual max.There was a delay of less than 60 minutes.There were no patient symptoms/complications.Initial reporter information and patient information cannot be provided due to the restriction by the privacy regulation.The product was replaced and was discarded.Device status reason: explanted-complete.The procedure was completed successfully.The tips of both the torque limiting drivers were stripped.No defect was found in the appearance of the torque limiting handle.The handle could lock with and detach from the driver smoothly.

• Brand Name: INFINITY OCCIPITOCERVICAL UPPER THORACIC SYSTEM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO, MED REL; road 909, km. 0.4., barrio mar; humacao PR 00792
• Manufacturer (Section G): MDT PUERTO RICO OPERATIONS CO, MED REL; road 909, km. 0.4., barrio mar; humacao PR 00792
• Manufacturer Contact: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 11468512
• MDR Text Key: 239387419
• Report Number: 2647346-2021-00013
• 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: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2021
• 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: H5643839
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2021
• Date Device Manufactured: 11/04/2020
• 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: 65 YR