MAUDE Adverse Event Report: STRYKER SPINE-US AERO C CAGE 6MM INTERBODY DEVICE, 14DX15W LORDOTIC; INTERVERTEBRAL BODY FUSION DEVICE

Model Number	48894066
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/09/2018
Type of Reportable Event	Malfunction
Event or Problem Description
During the implanting of a cage, the surgeon mentioned that he angled the inserter slightly both cephalad and caudal in order to try close a fish mouthing disc space.This strategy was implemented in the hopes of catching more bone and effectively seating the anchors in to as much bone as possible.The representative was made aware of this strategy post operatively.The surgeon does understand the correct on label use of the product but felt this additional technique was necessary with this particular patient.When the anchors were inserted, they entered the bone but pulled themselves out of the cage because of the increased angle and additional pressure, both breaking the cage and bending the titanium jacket.When the surgeon deemed the implant was damaged, a hybrid plate and screws were implanted over the construct at the same level (c4-c5) in order to ensure achieved proper fixation of the segment and a successful fusion at the correct surgical level.The surgery was completed successfully and there were no reports of adverse consequences to the patient.The surgeon was concerned about the stiffness of the connection between the implant and the inserter.However, upon follow up, it was determined that the inserter is performing as intended.
Additional Manufacturer Narrative
The reported event was confirmed via correspondence.Visual, dimensional and functional analysis could not be performed as the device was not returned.No relevant manufacturing issues were identified in the reported lot #.Conclusion: based on the information provided the plausible root causes of the reported event are over angulating the inserter during cage insertion, patient's anatomy, and not so robust connection between the inserter and the cage.
Event or Problem Description
During the implanting of a cage, the surgeon mentioned that he angled the inserter slightly both cephalad and caudal in order to try close a fish mouthing disc space.This strategy was implemented in the hopes of catching more bone and effectively seating the anchors in to as much bone as possible.The representative was made aware of this strategy post operatively.The surgeon does understand the correct on label use of the product but felt this additional technique was necessary with this particular patient.When the anchors were inserted they entered the bone but pulled themselves out of the cage because of the increased angle and additional pressure, both breaking the cage and bending the titanium jacket.When the surgeon deemed the implant was damaged, a hybrid plate and screws were implanted over the construct at the same level (c4-c5) in order to ensure achieved proper fixation of the segment and a successful fusion at the correct surgical level.The surgery was completed successfully and there were no reports of adverse consequences to the patient.The surgeon was concerned about the stiffness of the connection between the implant and the inserter.However, upon follow up it was determined that the inserter is performing as intended.

• Brand Name: AERO C CAGE 6MM INTERBODY DEVICE, 14DX15W LORDOTIC
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7242123
• Report Number: 0009617544-2018-00030
• Device Sequence Number: 18859996
• Product Code: ODP
• UDI-Device Identifier: 07613327124750
• UDI-Public: (01)07613327124750
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2018

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: Health Professional
• Device Model Number: 48894066
• Device Catalogue Number: 48894066
• Device Lot Number: 155727
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/09/2018
• Supplement Date Received by Manufacturer: 05/31/2018
• Initial Report FDA Received Date: 02/05/2018
• Supplement Report FDA Received Date: 06/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR