MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AERO C CAGE 7MM INTERBODY DEVICE, 12DX14W LORDOTIC; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number	48892076
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/27/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; during the case the surgeon questioned whether the anchors were seated.The patient had extraordinarily hard bone.The cranal caspar pin actually sheared during removal.The anchor appeared to be very close to sheared caspar pin.The next day the anchor was completely floating.Surgeon removed the floating anchor and placed an plate over top.He attempted to use an awl to pilot the screw.This would not work.He then tried a drill on hand and then using power.Neither of these would work.He then used a midas to pilot the holes.He destroyed a drill bit.Finally he was able to get a screw started with the second bit.
Additional Manufacturer Narrative
Method: device history review; complaint history review; risk assesment.Result: the customer reported event was confirmed via correspondence.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.There was a lack of anchor fully seated confirmation like tactile feedback as mentioned in the surgical technique; the activity of patient after surgery introduced too much instantaneous force so that the loose anchor completely back out of the channel and floated in the tissue, as mentioned in the risk file.Conclusion: the most likely cause of the reported event was determined to user related.
Event or Problem Description
It was reported that; during the case, the surgeon questioned whether the anchors were seated.The patient had extraordinarily hard bone.The cranal caspar pin actually sheared during removal.The anchor appeared to be very close to sheared caspar pin.The next day the anchor was completely floating.Surgeon removed the floating anchor and placed an plate over top.He attempted to use an awl to pilot the screw.This would not work.He then tried a drill on hand and then using power.Neither of these would work.He then used a midas to pilot the holes.He destroyed a drill bit.Finally he was able to get a screw started with the second bit.

• Brand Name: AERO C CAGE 7MM INTERBODY DEVICE, 12DX14W 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: 5743135
• Report Number: 0009617544-2016-00246
• Device Sequence Number: 56433
• Product Code: MAX
• UDI-Device Identifier: 07613327124668
• UDI-Public: (01)07613327124668
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2016

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: 48892076
• Device Lot Number: 155717
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/27/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/22/2016
• Supplement Report FDA Received Date: 08/26/2016
• 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