MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC; RETRACTOR

Model Number MSB_UNK_RETRACTOR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Exsanguination (1841)

Event Date 08/27/2017

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from healthcare professional via manufacturer representative regarding an event that occurred during a surgery as part of a clinical study on a patient with the following medical history and diagnosis: approximate duration of back pain symptoms that resulted in planned surgery: 96 months approximate duration of leg pain symptoms that resulted in planned surgery: 60 months how long has the patient been treated with conservative care? (complete 0 if no care): 96 months -non-smoker -physical therapy or osteopathy -bracing/orthroses -spinal injections/nerve blocks -pain medications -hyperlipidemia -osteoarthritis it was reported that the patient had a bleeding during surgery which required a blood transfusion of 1l.The bone bleeding at the level of the sarcum and afterwards at the level of the lower plateau of l5 was relatively important.Patient had vas score two days after surgery, on (b)(6) 2017 and was discharged on (b)(6) 2017.There is no product allegation regarding the retractor instrument.Product return status is unknown, and its replacement status is unknown.No other patient injury / complication was reported.

• Type of Device: RETRACTOR
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 10446793
• MDR Text Key: 204365010
• Report Number: 1030489-2020-01136
• Device Sequence Number: 1
• Product Code: GAD
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MSB_UNK_RETRACTOR
• Device Catalogue Number: MSB_UNK_RETRACTOR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/19/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Weight: 84