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); Patient-Device Incompatibility (2682); Positioning Problem (3009)
Health Effect - Clinical Codes	Pain (1994); Inadequate Pain Relief (2388)
Date of Event	10/09/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event is not a death situation.There was no life-threatening injury.However, this case may be considered as serious injury in the sense that the placement of a cage in a contraindicated situation may have resulted in the fracture of the c5 and c6 articular processes which had led to the cage migration toward the c6 nerve root area.The patient's altered cervical spine anatomy due to the combination of previous c6 corpectomy and segmental rotation of c5-c7 acdf was prone to higher risk for spinal damage and possible fluoroscopic imaging difficulty during surgery.The patient's pain was resolved post-revision with no new or worsening symptoms reported.Although there was no device defect or malfunction reported in this case, the original surgery possibly resulted in the articular process fracture contributed by the patient's anatomy and had led to the removal of the cage implant to relieve pain.From this perspective, the "migrated" implant in this case failed to perform as intended, and therefore the event is reported.Not device defect related.
Event or Problem Description
A patient, who had a c5-c7 acdf with c6 corpectomy two years ago (in 2012), experienced radicular symptoms (neck and arm pain) in 2013 and received a c5-c7 posterior cervical fusion on (b)(6) 2014.After the cervical fusion, the patient's radicular symptom (neck and arm pain) was not resolved.The surgeon discovered through post-op ct scan examination that the right c5 inferior articular process and right c6 superior process were fractured which may have led to a cage migration that resulted in the c6 nerve impingement.The patient received a revision to remove the cage located at c5-c6.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: 6090174
• Report Number: 3009394448-2016-00006
• Device Sequence Number: 1123933
• Product Code: ODP
• UDI-Device Identifier: 00852776006010
• UDI-Public: 00852776006010
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K122801
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/10/2014

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: 07/22/2016
• Device Model Number: PD-31-100
• Device Catalogue Number: PD-31-100
• Device Lot Number: 939342
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2014
• 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: 52 YR
• Patient Weight: 57