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

Model Number 55740006540

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Fever (1858)

Event Type  Injury  

Event Description

On (b)(6) 2021 mpxr-901578 (for, rep, hcp): information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having plif spinal therapy at l4/5 for lcs.It was reported that approximately 2mm the cage backed out.As an additional surgery the cage was removed and ilium inserted.The screws on both sides of l5 became loose.The patient has a fever and is suspected of being infected.There was no further information reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

On (b)(6) 2021 mpxr-901578 (for, rep, hcp): information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having plif spinal therapy at l4/5 for lcs.It was reported that approximately 2mm the cage backed out.As an additional surgery the cage was removed and ilium inserted.The screws on both sides of l5 became loose.The patient has a fever and is suspected of being infected.There was no further information reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: CD HORIZON® SPINAL SYSTEM
• 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: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 13058556
• MDR Text Key: 285615713
• Report Number: 1030489-2021-01587
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: 00613994995148
• UDI-Public: 00613994995148
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K202328
• 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: 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 55740006540
• Device Catalogue Number: 55740006540
• Device Lot Number: H5682278
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2021
• Date Device Manufactured: 05/06/2021
• 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
• Patient Sex: Male