MAUDE Adverse Event Report: MEDTRONIC CAPSTONE CAGE

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Stenosis (2263); Disability (2371); Patient Problem/Medical Problem (2688)

Event Date 02/13/2008

Event Type  Injury  

Event Description

On (b)(6) 2008, pt underwent 3-level plif involving three large infuse bone graft kits (pma 000058) used in combination with three capstone spacers (k073291).The combination of products was non-fda approved, the capstone spacers were not fda-cleared until april 24, 2008.Therefore there was no 510(k) clearance in effect when the capstone interbody cages were implanted into the pt.There was no investigational device exemption on (ide), no institutional review board (irb) approval and pt was not informed that the capstone device was non-fda approved or cleared.Pt developed bmp-induced bony overgrowth that escaped from the capstone devices, leading to compression of surrounding neurological structures, rendering the pt fully disabled.

• Brand Name: CAPSTONE CAGE
• Type of Device: CAPSTONE CAGE
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 5249609
• MDR Text Key: 32208826
• Report Number: MW5058083
• Device Sequence Number: 1
• Product Code: MAX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Disability
• Patient Age: 52 YR
• Patient Weight: 57