MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number G75447545

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Similar device with product number 75447545 with 510(k)# k042025 is marketed in us.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) via manufacturer representative regarding a patient spinal therapy for stenosis.It was reported that revision surgery was performed due to fracture occurred in l5, the screws of l5 were replaced, and plif was performed to l5-s1 additionally and fusion for extending was performed to iliac.The l1 screw and the l2 right screw were also loose, so they were replaced.There was patient involved in the event and no further complications reported regarding the event.

• Brand Name: CD HORIZON
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• 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: 10383795
• MDR Text Key: 202182890
• Report Number: 1030489-2020-01055
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G75447545
• Device Catalogue Number: G75447545
• Device Lot Number: H5481706
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/15/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/24/2018
• 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: 81 YR