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

Model Number	PD-31-200
Medical Device Problem Codes	Malposition of Device (2616); Positioning Problem (3009)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/16/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event is not a death or life-threatening situation.There was no serious injury or device malfunction of any kind reported.However, the malpositioned implant did not perform as intended and had led to an implant removal and replacement re-intervention.For the purpose of full compliance with 21 cfr 803, this case is reported out of abundance of caution.Not device defect related.
Event or Problem Description
A surgeon performed a cervical fusion for a patient and later discovered through post-operation x-ray images that a cage was malpositioned into the soft tissue area instead of the intervertebral joint as intended.The surgeon decided to perform a post-operation revision to remove and replace the malpositioned cage.There was no death or serious injury of any kind reported before or after the revision surgery.There was also no device malfunction reported in this case.

• Brand Name: DTRAX CERVICAL CAGE-B
• Common Device Name: DTRAX CERVICAL CAGE-B
• Manufacturer (Section D): PROVIDENCE MEDICAL TECHNOLOGY, INC.; 1331 n. california blvd.; suite 320; walnut creek CA 94596
• MDR Report Key: 6153706
• Report Number: 3009394448-2016-00009
• Device Sequence Number: 955728
• 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: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/16/2016

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: 02/13/2018
• Device Model Number: PD-31-200
• Device Catalogue Number: PD-31-200
• Device Lot Number: 1182759
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2016
• Initial Report FDA Received Date: 12/07/2016
• 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: 60 YR
• Patient Weight: 100