MAUDE Adverse Event Report: STRYKER SPINE-US ANCHOR C DIAM.3.5MM SELF DRILLING 12MM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL

Model Number	48335312
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Nausea (1970); Pain (1994); Dizziness (2194); Discomfort (2330)
Date of Event	03/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Imaging review of the device from the patient indicate that there is no product failure or malfunction.A supplemental report will be filed upon completion of the investigation.
Event or Problem Description
The patient called in to report that since cervical surgery in (b)(6) 2015, he's had pressure in his throat and no relief, neck pain, headaches that can and do become very severe, popping and shifting feeling in neck, ripping- grinding- feeling when turning head, loss of mental alertness, pain in throat that projects to my stomach, and list of others.At this time the patient had not had additional surgery.
Additional Manufacturer Narrative
Method: risk assessment; medical records, ct, mri and x-rays images were provided and evaluated by a medical expert and engineers.Results: visual, dimensional and functional analysis could not be performed as the device remains implanted.No lot # was provided, so a manufacturing record review could not be performed.Conclusion: the records review concluded that the patient¿s symptoms are non-specific.They may be related to a variety of sources including multiple surgeries.There are no focal neurological deficits reports to suggest that the screw is causing a problem.There is no information to reasonably suggest that the device has caused or contributed to the customer¿s reported symptoms.In performing our evaluation, the key objective is to attempt to determine root cause of potential involvement of the device and not to provide specific clinical diagnoses or evaluation.With the information provided the reported event does not appear to be a result of device failure.
Event or Problem Description
The patient called in to report that since cervical surgery in (b)(6) 2015, he's had pressure in his throat and no relief, neck pain, headaches that can and do become very severe, popping and shifting feeling in neck, ripping- grinding- feeling when turning head, loss of mental alertness, pain in throat that projects to my stomach, and list of others.At this time the patient had not had additional surgery.

• Brand Name: ANCHOR C DIAM.3.5MM SELF DRILLING 12MM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; -; allendale NJ 07401
• MDR Report Key: 7430803
• Report Number: 3005525032-2018-00024
• Device Sequence Number: 11253542
• Product Code: OVE
• UDI-Device Identifier: 04546540679840
• UDI-Public: (01)04546540679840
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K102606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 48335312
• Device Catalogue Number: 48335312
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/15/2018
• Supplement Date Received by Manufacturer: 04/25/2018
• Initial Report FDA Received Date: 04/13/2018
• Supplement Report FDA Received Date: 05/24/2018
• 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: Other
• Patient Age: 61 YR