MAUDE Adverse Event Report: STRYKER SPINE-US 9MM X 6DEG X11MM X 28MM; TRITANIUM® PL CAGE

Catalog Number	48955096
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	04/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Remains implanted.
Event or Problem Description
The physician reported a tritanium pl cage which fractured at l5-s1.The patient is doing well and the physician does not anticipate performing a revision surgery.
Additional Manufacturer Narrative
Visual, dimensional, functional inspection, and material analysis could not be performed as the device was not returned.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.It was confirmed via x ray that the tritanium pl cage was fractured.It was reported that the physician was very familiar with tritanium pl and the implant was not implanted at an angle, there was no cantilever force applied, no difficulty during insertion, and normal force was used for tlift trajectory crossing the midline to anterior cortex.The patient has normal activity patterns, no reports of falls, and hard bone quality with degenerative disc disease.Based on the information provided and a lack of device, a definite root cause cannot be determined at this time.It is possible that application of twist or torsion forces or use of the twist and distract methods during insertion could have contributed to the event, however this is unknown at this time.Capa 1769975 was opened on 9-april-2018.Goal of this capa was to determine the root cause(s) of this failure mode and implement actions to reduce occurrence.The post-market surveillance team will keep monitoring this type of reported events.H3 other text : implant remains in patient.
Event or Problem Description
The physician reported a tritanium pl cage which fractured at l5-s1.The patient is doing well and the physician does not anticipate performing a revision surgery.

• Brand Name: 9MM X 6DEG X11MM X 28MM
• Common Device Name: TRITANIUM® PL CAGE
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8558002
• Report Number: 3004024955-2019-00012
• Device Sequence Number: 19403473
• Product Code: MAX
• UDI-Device Identifier: 07613327118070
• UDI-Public: 07613327118070
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K160955
• 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): 07/29/2019

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 Catalogue Number: 48955096
• Device Lot Number: AKJ6
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/03/2019
• Supplement Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 04/26/2019
• Supplement Report FDA Received Date: 07/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR