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

Model Number	55740006540
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Fever (1858)
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: CD HORIZON® SPINAL SYSTEM
• Common Device Name: 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
• Report Number: 1030489-2021-01587
• Device Sequence Number: 11734523
• Product Code: KWP
• UDI-Device Identifier: 00613994995148
• UDI-Public: 00613994995148
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K202328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2021
• Initial Report FDA Received Date: 12/22/2021
• Date Device Manufactured: 05/06/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male