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

Catalog Number	54840047540
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Sleep Dysfunction (2517)
Date of Event	11/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product was not 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 per patient call that on (b)(6) 2018, the patient underwent 2 level discectomy, 1 level laminectomy and fusion at l3-s1.Post-op, the patient experienced pain in leg and back; and also had difficulty sleeping.Allegedly, the patient's vertebrae did not fuse as well.The patient underwent mri on (b)(6) 2018 due to back pain.Impression: overall satisfactory appearing postsurgical changes related to fusion of l3-4, l4-5, and l5-s1; however left lateral recess narrowing resulting in left s1 nerve root impingement at the l5-s1 level cannot be ruled out.The patient underwent myelogram of lumbar spine on (b)(6) 2018 due to back pain.Impression: 1.Postsurgical changes related to fusion of l3-4 through l5-s1.There is probable fusion of the right facets at l3-4.There is otherwise no indication of fusion as of yet.There is loosening of the right s1 screw and a fracture of the left s1 screw.2.The possible lateral recess compromise at l5-s1 noted on the prior mri appears to have been artifactual.Hence, on (b)(6) 2019, the patient underwent a revision surgery in which the hardware was removed and replaced.Patient condition is now reported to be healing.

• Brand Name: CD HORIZON SOLERA 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: 8762236
• Report Number: 1030489-2019-00703
• Device Sequence Number: 13963004
• Product Code: KWP
• UDI-Device Identifier: 00643169438651
• UDI-Public: 00643169438651
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K141494
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/04/2019

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: 54840047540
• Device Lot Number: H5262055
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2019
• Initial Report FDA Received Date: 07/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention