MAUDE Adverse Event Report: PROVIDENCE MEDICAL TECHNOLOGY, INC. DTRAX CERVICAL CAGE-B; CERVICAL INTERVERTEBRAL FUSION DEVICE

Model Number PD-31-200

Device Problems Malposition of Device (2616); Positioning Problem (3009)

Patient Problems Weakness (2145); Numbness (2415)

Event Date 12/02/2016

Event Type  malfunction  

Manufacturer Narrative

The event did not result in a death or a life-threatening injury.There was no device defect or malfunction reported with the devices.The patient experienced unrelieved numbness and weakness of the left arm since the initial cage implantation whose cause is uncertain.When a ct and emg scan was performed, the surgeon observed the cages were placed too medially.As a result, the surgeon performed a surgical re-intervention to remove all implanted cages from c4-c7 and, in addition, performed a laminotomy and foraminotomy.To date, the patient's symptoms still have not been resolved.For this reason, this event was reported.It is noted that this case used three different cage implant lots during procedure on the same day for the same patient.This mdr is for lot 1005037.The other two lots for this exact same case will be reported on separate mdrs.

Event Description

A patient who received posterior c4-c7 cervical intervertebral fusion on (b)(6) 2016 had to go through a re-intervention on (b)(6) 2017 to prevent the potential for permanent impairment of the left arm.The implanted cages were placed medially enough to result in the patient experiencing left arm numbness and weakness for about 6 months before the re-intervention.All implanted cervical cages from c4-c7 were removed with laminotomy and foraminotomy during procedure.But, the patient's symptoms are still not totally resolved.

• Brand Name: DTRAX CERVICAL CAGE-B
• Type of Device: CERVICAL INTERVERTEBRAL FUSION DEVICE
• Manufacturer (Section D): PROVIDENCE MEDICAL TECHNOLOGY, INC.; 1331 n. california blvd.; suite 320; walnut creek CA 94596
• Manufacturer (Section G): PROVIDENCE MEDICAL TECHNOLOGY, INC.; 1331 n. california blvd.; suite 320; walnut creek CA 94596
• Manufacturer Contact: margaret wong ; 1331 n. california blvd.; suite 320; walnut creek, CA 94596 ; 4159239376
• MDR Report Key: 6790415
• MDR Text Key: 83749167
• Report Number: 3009394448-2017-00005
• Device Sequence Number: 1
• Product Code: ODP
• UDI-Device Identifier: 00852776006003
• UDI-Public: 00852776006003
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122801
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/14/2018
• Device Model Number: PD-31-200
• Device Catalogue Number: PD-31-200
• Device Lot Number: 1005006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2016
• 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: 58 YR
• Patient Weight: 77