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	12/18/2016
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 in the right hand and thumb after the original implantation due to a mal-positioned cage placed too medially.The pain led to the re-intervention.Although there was no device defect or malfunction contributed to this case, the mal-positioned implant at c5-c6 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
Patient received a c5-c7 cervical fusion to treat a previously failed acdf fusion at the same levels.Patient woke up after the surgery with numbness and pain in the right hand and thumb.The surgeon took a post-op ct scan and determined that an implant was placed too medially which could contribute to the pain.The surgeon decided to perform a revision to remove the cage at c5-c6.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: 6123171
• Report Number: 3009394448-2016-00008
• Device Sequence Number: 16455806
• 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: 2015
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/19/2016

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: 08/14/2017
• Device Model Number: PD-31-200
• Device Catalogue Number: PD-31-200
• Device Lot Number: 1108924
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2015
• 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: 46 YR
• Patient Weight: 67