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

Model Number	PD-31-200
Medical Device Problem Codes	Malposition of Device (2616); Positioning Problem (3009)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	07/25/2016
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: PD-31-200
• Manufacturer (Section D): PROVIDENCE MEDICAL TECHNOLOGY, INC.; 1331 n. california blvd.; suite 320; walnut creek CA 94596
• MDR Report Key: 6122887
• Report Number: 3009394448-2016-00007
• Device Sequence Number: 632689
• Product Code: ODP
• UDI-Device Identifier: 00852776006003
• UDI-Public: 00852776006003
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/01/2016

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2016
• Initial Report FDA Received Date: 11/22/2016
• 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: 53 YR
• Patient Weight: 97