MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SOLERA SPINAL SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 54850016540

Device Problem Break (1069)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/08/2021

Event Type  malfunction  

Manufacturer Narrative

Radiographic image assessment - an interbody graft is present in post op x rays for l5-s1 fusion.There is a steep sacral slope and a paucity of bone present in the interbody space.Both of the sacral screws are fractured.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 a patient who had fusion l5/s1 due to scoliosis.It was reported that the doctor found out that the screw heads were apart from the screw body in ct.There were no patient symptoms/ complications as a result of the event.

• Brand Name: CD HORIZON SOLERA SPINAL SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• 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: 11936659
• MDR Text Key: 256201266
• Report Number: 1030489-2021-00735
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00643169491328
• UDI-Public: 00643169491328
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K143375
• 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: 06/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 54850016540
• Device Catalogue Number: 54850016540
• Device Lot Number: H5600318
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/08/2021
• Date Device Manufactured: 02/29/2020
• 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 Age: 10 YR