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); Patient-Device Incompatibility (2682); Positioning Problem (3009)

Patient Problems Pain (1994); Inadequate Pain Relief (2388)

Event Date 03/01/2016

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 unrelieved pain after the original procedure due to possible nerve impingement which may result when cages were not located in the intended joint space.The pain led to the re-intervention.The patient's "large facet" joint space as noticed by the surgeon may have contributed to cage movement leading to "subsidence".Although there was no device defect or malfunction reported in this case, the "subsided" implants led to a revision and therefore failed to perform as intended.For this reason, this event was reported.Not device defect related.

Event Description

A patient previously implanted with cervical cages from c4-t1 went through a revision on (b)(6) 2016 due to right arm and ulnar pain.The surgeon discovered through post-op x-ray examination that three cages had subsided "laterally" and came out easily when the surgeon used a kocher instrument to remove them during revision.The surgeon who performed the revision had noted that this patient has "large facets".All cages from c4-t1 were removed and replaced with hook and rod fusion.There was no device malfunction reported.The patient did not report any new or worsening symptoms after revision.

• 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: 6090128
• MDR Text Key: 59557314
• Report Number: 3009394448-2016-00002
• 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: 03/01/2016

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: 09/23/2017
• Device Model Number: PD-31-200
• Device Catalogue Number: PD-31-200
• Device Lot Number: 1121119
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2015
• 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: 54 YR
• Patient Weight: 75