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

Catalog Number	G7540020
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 or Problem Description
It was reported that on (b)(6) 2012, the patient underwent posterior lumbar fusion at l2-s1.On an unknown date, post-op, a clear zone around the screw on the right of s1 was noticed and the patient experienced pain in the right lower limb and lower back.Hence, a revision surgery was conducted on (b)(6) 2019, during which the set screw at right of s1 was found loosened, which led to a pain in the lower limb.The existing implant was removed and posterior lumbar interbody fusion was performed again at l5-s1-iliac.The patient's issue has now been reported as resolved.

• 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
• MDR Report Key: 8765028
• Report Number: 1030489-2019-00723
• Device Sequence Number: 14084261
• Product Code: KWP
• UDI-Device Identifier: 00613994143181
• UDI-Public: 00613994143181
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K052187
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/05/2019

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 Catalogue Number: G7540020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2019
• Initial Report FDA Received Date: 07/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SCREW
• Outcome Attributed to Adverse Event: Required Intervention