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 Pain (1994); Inadequate Pain Relief (2388)

Event Date 05/21/2015

Event Type  malfunction  

Manufacturer Narrative

The event is not a death situation.There was no life-threatening injury or any serious injury that resulted in permanent impairment of body function or structure reported.However, there was illness in the sense that the patient experienced new pain after the original implantation due to a mal-positioned cage.The pain led to the re-intervention.Although there was no device defect or malfunction reported in this case, the mal-positioned implant at c4-c5 led to a revision 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 posterior cervical fusion and experienced new right arm pain after surgery.The surgeon discovered through post-op ct scan examination that the cage at c4-c5 was placed a little too anteriorly.The patient was taken back to the or and received a revision to remove that cage at c4-c5 without replacement.It was reported that the patient's pain was resolved without any new or worsening symptoms after revision.There was no device malfunction reported in this case.

• 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: 6090147
• MDR Text Key: 59579544
• Report Number: 3009394448-2016-00004
• 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: Other
• Type of Report: Initial
• Report Date: 05/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/15/2017
• Device Model Number: PD-31-200
• Device Catalogue Number: PD-31-200
• Device Lot Number: 1037345
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2015
• 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: 72 YR
• Patient Weight: 84