MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC LONGITUDE

Model Number MSB_UNK_LONGITUDE

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/01/2022

Event Type  Injury  

Event Description

Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having screw replacement and extension.It was reported that the tip was broken when the screw for replacement was being removed.The debris was collected with a tweezer.No residue in the body.A lot of cleaning was performed just in case.The screw was removed successfully with another driver, and the screw was replaced with a new one.There was procedural delay for less than 60 mins.The screw was replaced because the l5 screw was loose.Also, a fixed extension was performed due to a th11 compression fracture.Even though the looseness of the screw in the l5 was observed in the surgery, it was not the cause of the fracture.Therewere no further complications reported regarding the event.

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.

• Brand Name: LONGITUDE
• 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: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 14208088
• MDR Text Key: 290098581
• Report Number: 1030489-2022-00400
• Device Sequence Number: 1
• Product Code: OSH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MSB_UNK_LONGITUDE
• Device Catalogue Number: MSB_UNK_LONGITUDE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2022
• 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): Required Intervention
• Patient Sex: Female