MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SOLERA VOYAGER SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 55750015545

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

Patient Problems Internal Organ Perforation (1987); Ulcer (2274)

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 healthcare professional via field representative regarding patient with infection of l3-4 involved in spinal therapy.Levels implanted: th11-s.It was reported that during use, backed-out screws contacted skin to form pressure ulcer and perforation.There was patients symptoms/ complications reported as a result of the event.There was no delay in overall procedure time.Patient was not hospitalized prolong as a result of the event.Skin flap formation and plastic was performed by department of plastic surgery to extend the fixation on (b)(6) 2020.It was reported patient issue is resolved.There was health damage on the patient reported due to screw back out.On (b)(6) 2020, received additional information that levels screw backed out was l1-l2.Reported all 4 screws backed out hence in revision surgery screws were removed and returned to patient.Confirmed revision surgery was performed due to backed-out screws contacted skin to form pressure ulcer and perforation.Flap formation was performed by plastic surgery.Revision surgery was performed to extend the fixation on (b)(6) 2020 at levels:th10-l2.

• Brand Name: CD HORIZON SOLERA VOYAGER SPINAL SYSTEM
• 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: 10927078
• MDR Text Key: 218957756
• Report Number: 1030489-2020-01725
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K170679
• 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: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 55750015545
• Device Catalogue Number: 55750015545
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention