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

Model Number	PD-31-200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Weakness (2145); Patient Problem/Medical Problem (2688)
Date of Event	11/12/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event is not a death situation.There was no life-threatening injury.There was no device malfunction reported in this case either.It was noted that the patient has previous acdf and severe kyphosis in this case.This patient's anatomy and condition may be contributing to the nerve palsy and weakness as well as the facet fracture.Although there was no nerve impingement evident in the ct images that could be contributing to the patient's post-operation symptoms and leading to a re-intervention, there was facet fracture with unknown cause reported.For this reason, providence decided to report this event out of abundance of caution to comply with 21 cfr 803 requirements.It is also noted that there are two different lots involved in this case.This mdr reports one of the two lots (lot 1096682) used in this case (used on the same patient, on the same day, and by the same surgeon).Not device defect or malfunction related.
Event or Problem Description
Patient had severe kyphosis and a c4-c7 acdf in (b)(6) 2015 prior to receiving posterior cervical fusion.After the cervical fusion, the patient woke up with nerve palsy and weakness.The patient's symptom was monitored by the surgeon who had a concern that the combination of nerve palsy and weakness could be due to possible proximity of the implant to artery nerves and facet fracture.The surgeon later confirmed that there was no intervention necessary because ct images showed the implant was not impinging on any nerves.However, the cause of the facet fracture was inconclusive according to the surgeon.The patient did not report any new or worsening symptoms after the revision.There was also no device defect or malfunction of any type reported.
Additional Manufacturer Narrative
The event is not a death situation.There was no life-threatening injury.There was no device malfunction reported in this case either.It was noted that the patient has previous acdf and severe kyphosis in this case.This patient's anatomy and condition may be contributing to the nerve palsy and weakness as well as the facet fracture.Although there was no nerve impingement evident in the ct images that could be contributing to the patient's post-operation symptoms and leading to a re-intervention, there was facet fracture with unknown cause reported.For this reason, providence decided to report this event out of abundance of caution to comply with 21 cfr 803 requirements.It is also noted that there are two different lots involved in this case.This mdr reports one of the two lots (lot 1096682) used in this case (used on the same patient, on the same day, and by the same surgeon).Note: this mdr is a follow-up (supplemental) mdr to correct a possible lot number error in the original submission.The original submission possibly entered lot 1116223 instead of 109668.Not device defect or malfunction related.
Event or Problem Description
Patient had severe kyphosis and a c4-c7 acdf in (b)(6) 2015 prior to receiving posterior cervical fusion.After the cervical fusion, the patient woke up with nerve palsy and weakness.The patient's symptom was monitored by the surgeon who had a concern that the combination of nerve palsy and weakness could be due to possible proximity of the implant to artery nerves and facet fracture.The surgeon later confirmed that there was no intervention necessary because ct images showed the implant was not impinging on any nerves.However, the cause of the facet fracture was inconclusive according to the surgeon.The patient did not report any new or worsening symptoms after the revision.There was also no device defect or malfunction of any type reported.

• Brand Name: DTRAX CERVICAL CAGE-B
• Common Device Name: INTERVERTEBRAL CERVICAL FUSION DEVICE
• Manufacturer (Section D): PROVIDENCE MEDICAL TECHNOLOGY, INC.; 1331 n. california blvd.; suite 320; walnut creek CA 94596
• MDR Report Key: 6179699
• Report Number: 3009394448-2016-00011
• Device Sequence Number: 13685216
• Product Code: ODP
• UDI-Device Identifier: 00852776006003
• UDI-Public: 00852776006003
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K122801
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2015

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: 07/21/2017
• Device Model Number: PD-31-200
• Device Catalogue Number: PD-31-200
• Device Lot Number: 109668
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/12/2015
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/15/2016
• Supplement Report FDA Received Date: 01/04/2017
• 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: 57 YR
• Patient Weight: 73