MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AERO C CAGE 7MM INTERBODY DEVICE, 14DX15W LORDOTIC; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number	48894076
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Injury (2348)
Date of Event	05/05/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during fusion c5-c6 on an osteoporotic patient (poor/ mushy bone quality) the vertebral body cracked/fractured while inserting the blade.The surgery was completed by inserting a blade over the fractured portion and inserting 2 screws.A plate was placed on c4-c5.No adverse consequences of the patient reported.The patient will be under observation.
Additional Manufacturer Narrative
Method: device history review; complaint history review; risk assessment.Results: the customer reported event was confirmed via correspondence.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Conclusion: the most likely cause of the reported event was determined to be related to the osteoporotic patient's poor/mushy bone quality.
Event or Problem Description
It was reported that during fusion c5-c6 on an osteoporotic patient (poor/ mushy bone quality) the vertebral body cracked/fractured while inserting the blade.The surgery was completed by inserting a blade over the fractured portion and inserting 2 screws.A plate was placed on c4-c5.No adverse consequences of the patient reported.The patient will be under observation.

• Brand Name: AERO C CAGE 7MM INTERBODY DEVICE, 14DX15W LORDOTIC
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5678248
• Report Number: 0009617544-2016-00204
• Device Sequence Number: 16191824
• Product Code: MAX
• UDI-Device Identifier: 07613327124866
• UDI-Public: (01)07613327124866
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2016

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?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 48894076
• Device Lot Number: 155728
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/05/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/25/2016
• Supplement Report FDA Received Date: 08/05/2016
• 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: Other