MAUDE Adverse Event Report: MEDTRONIC INFUSE BONE GRAFT

Device Problem Patient-Device Incompatibility (2682)

Patient Problems High Blood Pressure/ Hypertension (1908); Pain (1994); Electrolyte Imbalance (2196); Test Result (2695)

Event Date 10/10/2005

Event Type  Injury  

Event Description

Dr.(b)(6) inserted bone cement, medtronic infuse bone graft, into spine; resulting in blood pressure problems and continuous back pain.Causing potassium and calcium to be replaced continually with add'l medications.Depleted all natural levels.Surgery dates at (b)(6) in (b)(6).Add'l surgeries at (b)(6).Reference: fortune magazine, bad to the bone: a medical horror story, 09/18/2012.Why was the person using the product: utilized during spinal surgery.

• Brand Name: INFUSE BONE GRAFT
• Type of Device: INFUSE BONE GRAFT
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 4838232
• MDR Text Key: 5943716
• Report Number: MW5043044
• Device Sequence Number: 1
• Product Code: NEK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Patient Sequence Number: 1
• Treatment: TRAMODOL HCL 50MG; DHEA 25MG; PAXIL; STOOL SOFTNERS; PREMPRO; PROBIOTIC 8; MUCINEX 1200; CO Q10; CALCIUM 600MG X2; D3 1000 IU; KLORCON 10MFQ X 4; POTASIUM 99MG X 2; HCT 25MG; CLONAZEPAM 1MG X2; TYLENOL; ALLERGEY RELIEF; ESTRADIOL 5MG; DIOVAN 160MG
• Patient Outcome(s): Disability
• Patient Age: 50 YR
• Patient Weight: 57