MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Device Problem Malposition of Device (2616)

Patient Problems Hematoma (1884); Nerve Damage (1979); Blood Loss (2597)

Event Date 04/23/2010

Event Type  Injury  

Manufacturer Narrative

(b)(4).Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.

Event Description

It was reported that on (b)(6) 2010, the patient underwent thoracic spine revision, fixation by instrumentation and the use of bone cement.Intra op complication included blood loss.On (b)(6) 2010, patient was admitted due to retroperitoneal hematoma, anemia, respiratory failure and kidney failure.X-rays showed that the orthopedic screws placed during surgery had breached the surface of vertebral bodies and caused bleeding by exposing blood vessels and soft tissues to sharp edges.Breach of the vertebral surface by screws and injury to the overlying tissue with hematoma formation was observed.Subsequently the patient underwent 3 additional spinal surgeries.Post op complication includes hardware malpositioning, cement migration, spinal cord complication, retroperitoneal hematoma peripehral neuromuscular degeneration and loss of function in her arms and legs, and of cervical nerve plexus damages.

• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6823326
• MDR Text Key: 83767983
• Report Number: 1030489-2017-01961
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 08/03/2017

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/03/2017
• Initial Date FDA Received: 08/28/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention