MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG UNKNOWN; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number MSB_UNK_SCREW

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Failure of Implant (1924)

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

Information was received from a healthcare provider via a manufacturer representative regarding a patient with pre-operative diagnosis of collapse of l3.It was revision surgery.In the initial surgery on june 24,2019, pf was performed at l2-5 due to the collapse of l3.Then on (b)(6) 2019, fusion for extending was performed between s1 and il.After that, removal was performed at l2, l5 and s1, and two screws were inserted additionally on each side of il on (b)(6) 2019.In this surgery done on (b)(6) 2020, removal was performed at l3, and screw was inserted additionally at t12, l1, l2 and l3 to connect and fusion for extending was performed due to the collapse of l1.There was health damage on the patient.Allegation for pli 20 is fusion for extending was performed due to the collapse of l1.It is unknown if the product contributes the reported event.

• Brand Name: UNKNOWN
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer (Section G): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer Contact: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 10956694
• MDR Text Key: 219938571
• Report Number: 1030489-2020-01747
• Device Sequence Number: 1
• Product Code: NKB
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MSB_UNK_SCREW
• Device Catalogue Number: MSB_UNK_SCREW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2020
• 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 Age: 76 YR