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

Catalog Number	55840006550
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/21/2020
Type of Reportable Event	Malfunction
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
Pre op diagnosis: instability (up to and including grade 2 spondylolisthesis, retrolisthesis or lateral listhesis) procedure performed: posterior lumbar fusion (plf) with l5/s1 transforaminal lumbar interbody fusion (tlif) levels implanted: l2/l3; l3/l4; l4/l5; l5/s1 event date: (b)(6) 2020 <(>&<)> (b)(6) 2020 post op, medical image review showed that no graft at l3-l4,l4-l5.Sup/inf lucent lines not seen with this graft type; right/left interbody bone obscured by overlying bone; s1 screws both loose and upper sacral fragmentation; adjudicated.Both s1 screws with evidence of loosening.There were no complications to the patient.

• 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: 10423952
• Report Number: 1030489-2020-01091
• Device Sequence Number: 11497651
• Product Code: KWP
• UDI-Device Identifier: 00613994972019
• UDI-Public: 00613994972019
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K113174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 55840006550
• Device Lot Number: H5516513
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2020
• Initial Report FDA Received Date: 08/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 105