MAUDE Adverse Event Report: STRYKER SPINE-US AVS AS SPACER 7 X 12 X 14 X 4 DEG; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL

Model Number	48322074
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Autoimmune Disorder (1732); Dysphagia/ Odynophagia (1815); Fatigue (1849); Itching Sensation (1943); Memory Loss/Impairment (1958); Nerve Damage (1979); Swelling (2091); Myalgia (2238); Injury (2348); Numbness (2415); Neck Pain (2433); Weight Changes (2607)
Date of Event	06/01/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that he patient started having ongoing issues since surgery which include itching, fatigue, myalgia, further into the year having gastro-intestinal issues, neck pain, numbness in arms and hands as well as face, uncomfortable swallowing, skin bumps and break outs around neck, chest and upper back, and brain fog.Patient has had testing done, has tested positive autoimmune issue, 10 lb.Weight loss in a short period without reason.Doc severed long thoracic nerve and damaged c7 nerve.
Additional Manufacturer Narrative
Upon further correspondence, the patient indicated undergoing revision surgery to have hardware removed.Patient reported waking up pain free.Lot number of the device was not provided therefore complaint history review and device history review cannot be performed.The device was not returned for evaluation.Surgical technique warns about foreign body sensitivity.Where material sensitivity is suspected appropriate tests should be made prior to material implantation.No further investigation can be performed due to insufficient information provided.It cannot be determined at this time if any of the implanted devices malfunctioned or contributed to patient's symptoms.
Event or Problem Description
It was reported that he patient started having ongoing issues since surgery which include itching, fatigue, myalgia, further into the year having gastro-intestinal issues, neck pain, numbness in arms and hands as well as face, uncomfortable swallowing, skin bumps and break outs around neck, chest and upper back, and brain fog.Patient has had testing done, has tested positive autoimmune issue, 10 lb.Weight loss in a short period without reason.Doc severed long thoracic nerve and damaged c7 nerve.

• Brand Name: AVS AS SPACER 7 X 12 X 14 X 4 DEG
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7603505
• Report Number: 0009617544-2018-00143
• Device Sequence Number: 1383535
• Product Code: ODP
• UDI-Device Identifier: 07613154261314
• UDI-Public: (01)07613154261314
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K120486
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2018

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: No Information
• Device Model Number: 48322074
• Device Catalogue Number: 48322074
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/15/2018
• Supplement Date Received by Manufacturer: 07/30/2018
• Initial Report FDA Received Date: 06/14/2018
• Supplement Report FDA Received Date: 08/10/2018
• 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: 34 YR