MAUDE Adverse Event Report: STRYKER SPINE-US 10MM X6DEG X 9MM X 28MM; INTERVERTEBRAL BODY FUSION DEVICE

Model Number	48954106
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	02/20/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the cage was discovered fractured at the level of l4/l5 in an x-ray, post operatively.There was no fusion in the cage.Initial surgery took place on (b)(6) 2016, after which the patient experienced pain and visited the doctor¿s office.In addition to the cage, the patient was implanted with another device manufacturer's screws and bone graft.The screws were reported broken and imaging indicated there is an inflammation response to the other device manufacturer's bone graft around the cage.Upon follow-up, it was reported that the patient will undergo revision surgery.
Additional Manufacturer Narrative
Method: device history review, complaint history review, risk assessment.Result: the reported event was confirmed via correspondence.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Conclusion: the most likely root cause was determined to instantaneous overload applied on the cage after the supplemental fixation system was broken.
Event or Problem Description
It was reported that the cage was discovered fractured at the level of l4/l5 in an x-ray, post operatively.There was no fusion in the cage.Initial surgery took place on (b)(6) 2016, after which the patient experienced pain and visited the doctor¿s office.In addition to the cage, the patient was implanted with another device manufacturer's screws and bone graft.The screws were reported broken and imaging indicated there is an inflammation response to the other device manufacturer's bone graft around the cage.Upon follow-up, it was reported that the patient will undergo revision surgery.Additional information (b)(6) 2018: revision surgery took place on (b)(6) 2018.A new cage was implanted along with supplemental fixation system.The patient is doing well after the revision surgery.The original supplemental fixation system was explanted and retained by the patient.2 screws and 1 rod were reported broken.
Event or Problem Description
It was reported that the cage was discovered fractured at the level of l4/l5 in an x-ray, post operatively.There was no fusion in the cage.Initial surgery took place on (b)(6), 2016, after which the patient experienced pain and visited the doctor¿s office.In addition to the cage, the patient was implanted with another device manufacturer's screws and bone graft.The screws were reported broken and imaging indicated there is an inflammation response to the other device manufacturer's bone graft around the cage.Upon follow-up, it was reported that the patient will undergo revision surgery.Additional information 03/26/2018: revision surgery took place on (b)(6), 2018.A new cage was implanted along with supplemental fixation system.The patient is doing well after the revision surgery.The original supplemental fixation system was explanted and retained by the patient.2 screws and 1 rod were reported broken.

• Brand Name: 10MM X6DEG X 9MM X 28MM
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7331353
• Report Number: 3004024955-2018-00011
• Device Sequence Number: 144614
• Product Code: MAX
• UDI-Device Identifier: 07613327117974
• UDI-Public: (01)07613327117974
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K160955
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/26/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 48954106
• Device Catalogue Number: 48954106
• Device Lot Number: AAAA
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/20/2018
• Supplement Date Received by Manufacturer: 03/26/2018; 08/28/2018
• Initial Report FDA Received Date: 03/12/2018
• Supplement Report FDA Received Date: 03/29/2018; 09/26/2018
• 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: Required Intervention
• Patient Age: 56 YR