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

Model Number	PD-31-100
Medical Device Problem Codes	Malposition of Device (2616); Positioning Problem (3009)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Weakness (2145); Disability (2371); Numbness (2415); Nerve Proximity Nos (Not Otherwise Specified) (2647)
Date of Event	07/25/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event is not a death situation.There was no life-threatening injury or any device defect reported either.However, there was prolonged unresolved post-operation symptoms experienced by the patient that may be due to implant positioning close to the c5 nerve.Although there was no device defect or out-of-specification malfunction reported in this case, the positioning of the implant may have led to the unresolved arm weakness and finger numbness and therefore failed to perform as intended.For this reason and out of abundance of caution to comply with 21 cfr 803 requirements, this event was reported.Device not returned for evaluation.
Event or Problem Description
The patient had a previous c5-c7 foraminotomy surgery in 2007 due to heaviness in the right arm when lifting, weak triceps, tingling in the fingers, and pain down the arm when extending the neck (e.G.Looking up) but not bending the neck in flexion (e.G.Looking down).In mid-2015, the patient started to experience the return of the pre-2007 symptoms.Ct scan showed bone spurs at c4-c5.On (b)(6) 2015, the patient received a cervical fusion procedure using providence cage-t implant.Two days after the surgery, the patient reported difficulty flexing his right elbow (couldn't lift more than 2 lbs.And "the right deltoid and triceps were out").The symptoms did not go away after taking medrol prescribed by the surgeon who did the implant.The patient, after reviewing the intra-op x-ray images, reported seeing the implant was slightly proud into the right foramen possibly interfering with c5 nerve.The unresolved symptoms, right-hand weakness and numbness bilaterally in index and thumb phalanges, continues to-date without any indication of improvement.There was no device defect or re-intervention indicated in this case.It is noted that the patient is a spinal surgeon himself.(b)(4) was notified of this situation in may 2017.

• Brand Name: DTRAX CERVICAL CAGE-T
• Common Device Name: CERVICAL INTERVETEBRAL FUSION DEVICE
• Manufacturer (Section D): PROVIDENCE MEDICAL TECHNOLOGY, INC.; 1331 n. california blvd.; suite 320; walnut creek CA 94596
• MDR Report Key: 6622774
• Report Number: 3009394448-2017-00001
• Device Sequence Number: 614384
• Product Code: ODP
• UDI-Device Identifier: 00852776006010
• UDI-Public: 00852776006010
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 05/15/2017

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: 01/19/2017
• 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: 05/15/2017
• Initial Report FDA Received Date: 06/08/2017
• 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: Disability
• Patient Age: 72 YR
• Patient Weight: 79