MAUDE Adverse Event Report: PROVIDENCE MEDICAL TECHNOLOGY, INC. DTRAX CERVICAL CAGE-B; PD-31-200

Model Number PD-31-200

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

Patient Problem Inadequate Pain Relief (2388)

Event Date 07/25/2016

Event Type  malfunction  

Manufacturer Narrative

The event is not a death or life-threatening situation.There was no serious injury that resulted in permanent impairment of body function or structure reported.However, there was illness in the sense that the patient experienced post-op pain after the original implantation possibly due to a mal-positioned cage.The pain led to the re-intervention.Although there was no device defect or malfunction contributed to this case, the mal-positioned implant at c3-c4 led to a re-intervention and therefore failed to perform as intended.For this reason, this event was reported to fully comply with 21 cfr 803.Not device defect related.

Event Description

A patient received a c3-c4 cervical fusion and later experienced some post-surgery pain.The surgeon discovered through x-ray images that one of the cages was positioned laterally into the soft tissue area.The surgeon decided to perform a revision to remove and replace the malpositioned cage.The patient did not report any further or worsening symptoms after the revision.There was no device malfunction in this case.

• Brand Name: DTRAX CERVICAL CAGE-B
• Type of Device: PD-31-200
• 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: 6122887
• MDR Text Key: 60751110
• Report Number: 3009394448-2016-00007
• 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: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/20/2018
• Device Model Number: PD-31-200
• Device Catalogue Number: PD-31-200
• Device Lot Number: 1004457
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2016
• 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: 53 YR
• Patient Weight: 97