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 Bone Fracture(s) (1870)

Event Date 07/28/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

M120401006, the information was received from the clinical department for a patient regarding a spinal therapy.It was reported that the patient had osteoporotic fracture.Osteoporotic fracture of l4, l5, subsidence of cages, l4 screw displacement in fracture into disc l3/4.No clinical symptoms.Was assessment for product/therapy/procedure relatedness made by the investigator - yes relevant assessment/allegation: probably related to the progression of degenerative lumbar spine was assessment for product/therapy/procedure relatedness made by the sponsor - yes was an assessment for product/therapy/procedure relatedness made by the cec - no ae outcome: ongoing relevant patient medical history: -hypertension -renal insufficiency -coronary heart disease -cancer -respiratory disease (copd, asthma) -depression / anxiety medications: anti-epileptic medications ae description: probably no consequence to implanted device - bone condition problem.Ae diagnosis: osteoporotic fracture l4, l5.

• 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: 10783363
• MDR Text Key: 215975906
• Report Number: 1030489-2020-01580
• Device Sequence Number: 1
• Product Code: GAD
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2020
• Was Device Evaluated by Manufacturer?: No
• 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: 85 YR
• Patient Weight: 53