MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK CAPSTONE SPINAL SYSTEM; INTERVERTEBRAL BODY FUSION CAGE 26 X 12MM

Model Number 2991226

Device Problem Off-Label Use (1494)

Patient Problems Cyst(s) (1800); Reaction (2414)

Event Date 02/13/2008

Event Type  Injury  

Event Description

On (b)(6) 2008, medtronic consultant dr.(b)(6) implanted therapeutic biologic bone morphogenetic protein in combination with interbody cage(s) into patient with cd horizon supplemental fixation at (b)(6) hospital in (b)(6).The biologic is distributed under trade name capstone spine system (sizes were 26 x 12mm and 26 x 8mm).The combination of infuse and capstone cages required pma under 21 cfr 888.3080.No pma was obtained prior to commercial distribution.The capstone devices were distributed into commerce and implanted into patient nearly 7 weeks prior to receiving final clearance order on (b)(6) 2008 under k073291.Patient developed post-operative complications, including but not limited to worsening of pre-operative symptoms, bmp-induced ectopic bone growth and a cyst near the implant site.Revision surgery was conducted on (b)(6) 2010 to explant supplemental fixation devices, debride the cyst.

• Brand Name: CAPSTONE SPINAL SYSTEM
• Type of Device: INTERVERTEBRAL BODY FUSION CAGE 26 X 12MM
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK
• MDR Report Key: 4182008
• MDR Text Key: 17571257
• Report Number: MW5038624
• 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: 10/10/2014
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2991226
• Was the Report Sent to FDA?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 52 YR
• Patient Weight: 57