MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON® SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number 55711016540

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Unspecified Nervous System Problem (4426)

Event Date 03/15/2022

Event Type  malfunction  

Manufacturer Narrative

This part is not approved for use in the united states; however a like device catalog # 55811015540, 510k # k122433 and udi # (b)(4) was cleared in the united states.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 received from healthcare provider via manufacturer representative regarding an event happened during post-op of the reported product.Patient medical history includes ais.It was reported that, when the screws were checked after the surgery, they were deviated.The patient also developed neurological symptoms.Revision surgery was performed to explant and replace the screws.The levels implanted were left of l2/3/4 and a total of three screws were deviated.6.5×35 was re-used and re-inserted during the reoperation and rest of the two were discarded.It was confirmed by postoperative ct imaging regarding deviation.It is unknown whether the cause was a screw deviation, but neurological symptoms have manifested.The procedure or technique performed during initial surgery was scoliosis correction and fixation and levels implanted were t4-l5.The number of days hospitalized was extended because of the repeat surgery.The status of patient was mentioned as recovering, the reported product was explanted.No further complications reported.

• Brand Name: CD HORIZON® SPINAL SYSTEM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• 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: 14100474
• MDR Text Key: 289195422
• Report Number: 1030489-2022-00349
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: SEE H10
• 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: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 55711016540
• Device Catalogue Number: 55711016540
• Device Lot Number: CA21D048
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2022
• Date Device Manufactured: 10/12/2021
• 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; Hospitalization
• Patient Age: 17 YR
• Patient Sex: Female