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

Model Number	PD-31-100
Medical Device Problem Codes	Malposition of Device (2616); Positioning Problem (3009)
Health Effect - Clinical Codes	Pain (1994); Inadequate Pain Relief (2388)
Date of Event	05/05/2015
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 illness in the sense that the patient experienced pain after the original implantation due to a mal-positioned cage.The pain led to the re-intervention.Although there was no device defect or malfunction reported in this case, the mal-positioned implant had led to a revision 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 who had prior acdf received a posterior cervical fusion and experienced pain after surgery.The surgeon discovered through post-op ct scan examination that one of the cages was placed too medially resulting in nerve root impingement.The patient received a revision to remove that cage.The patient did not report any new or worsening symptoms after revision.There was no device malfunction reported in this case.

• Brand Name: DTRAX CERVICAL CAGE-T
• Common Device Name: CERVICAL INTERVERTEBRAL FUSION DEVICE
• Manufacturer (Section D): PROVIDENCE MEDICAL TECHNOLOGY, INC.; 1331 n. california blvd.; suite 320; walnut creek CA 94596
• MDR Report Key: 6090154
• Report Number: 3009394448-2016-00005
• Device Sequence Number: 1641105
• Product Code: ODP
• UDI-Device Identifier: 00852776006010
• UDI-Public: 00852776006010
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 06/03/2015

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: 01/30/2017
• Device Model Number: PD-31-100
• Device Catalogue Number: PD-31-100
• Device Lot Number: 1015043
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2015
• Initial Report FDA Received Date: 11/09/2016
• 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: 51 YR
• Patient Weight: 82