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

Model Number	PD-31-200
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Unintended Movement (3026)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/13/2015
Type of Reportable Event	Malfunction
Additional 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 new post-operation pain experienced by the patient likely due to implant migration during fusion resulted from the patient's active lifestyle.The pain led to the re-intervention.Although there was no device defect or malfunction reported in this case, the migrated implant led to a revision and therefore failed to perform as intended.For this reason and out of abundance of caution to comply with 21 cfr 803 requirements, this event was reported.Please note the event conclusion code (b)(4) in this mdr report is referring to the patient, not the surgeon or user.Not device defect or malfunction related.
Event or Problem Description
A patient received cervical fusion but did not follow the surgeon's post-operation advice to wear a soft collar to help stabilize the spine during fusion and was active in gaming within 14 days of the surgery.This patient later experienced pain on his right arm.The surgeon believed the gaming activity could have led to an implant migration resulted in the observed pain.The surgeon decided to perform a revision surgery to remove and replace the implant.The patient did not report any new or worsening symptoms after the revision.There was also no reported device malfunction before or after the revision.

• Brand Name: DTRAX CERVICAL CAGE-B
• Common Device Name: INTERVERTEBRAL CERVICAL FUSION DEVICE
• Manufacturer (Section D): PROVIDENCE MEDICAL TECHNOLOGY, INC.; 1331 n. california blvd.; suite 320; walnut creek CA 94596
• MDR Report Key: 6178292
• Report Number: 3009394448-2016-00010
• Device Sequence Number: 929794
• Product Code: ODP
• UDI-Device Identifier: 00852776006003
• UDI-Public: 00852776006003
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K122801
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 11/10/2016
• Device Model Number: PD-31-200
• Device Catalogue Number: PD-31-200
• Device Lot Number: 981008
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2015
• Initial Report FDA Received Date: 12/15/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Weight: 100