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

Model Number	PD-31-200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/14/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event did not result in death.There was no serious or life-threatening injury that resulted in permanent impairment of body function or structure reported.There was no physical device defect or malfunction reported in this case.Although there was no physical device defect or malfunction reported in this case, the implant was considered "malfunctioned" because it failed to perform as intended.The persistence of symptoms resulted in a re-intervention.It is noted that there were three lots of cervical cages used in the procedure: lot 1004457 (expiration on 4/20/2018), 1176498 (expiration on 1/25/2018), and 1210738 (expiration on 4/18/2018).The full patient id is (b)(6), which could not be entered fully in a previous section of this form due to space constraint.Device not returned for evaluation.
Event or Problem Description
A surgeon performed a cervical fusion at c4-c7 on (b)(6) 2016 using cervical cages.Following the initial surgery, the patient's symptoms were not resolved.The patient consulted a second surgeon for another opinion.Upon examination and imaging studies, the second surgeon determined cage placement at c4-c5 was too medial and potentially causing nerve irritation.On (b)(6) 2016, the second surgeon revised the original cervical fusion by removing the initially placed cervical cages and implanting lateral mass screws and rods from c4-c7.The revision surgery was completed without incident.

• Brand Name: DTRAX CERVICAL CAGE-B
• Common Device Name: INTERVETEBRAL FUSION DEVICE
• Manufacturer (Section D): PROVIDENCE MEDICAL TECHNOLOGY, INC.; 1331 n. california blvd.; suite 320; walnut creek CA 94596
• MDR Report Key: 6012716
• Report Number: 3009394448-2016-00001
• Device Sequence Number: 10864839
• Product Code: ODP
• UDI-Device Identifier: 00852776006003
• UDI-Public: 00852776006003
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/07/2016

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, 1176498, AND 1210738
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2016
• Initial Report FDA Received Date: 10/07/2016
• 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: 44 YR
• Patient Weight: 43