MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CLYDESDALE PTC SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	4986250
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Neuropathy (1983); Hernia (2240)
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 the patient underwent oblique lumbar interbody fusion (olif) at l4/5 due to lumbar spinal canal stenosis (lscs).In which, a cage was implanted.Post-op, disc herniation was noted and lateral hernia was detected (after performing mri) at the same place where the cage was implanted.Hence, a herniation removal surgery (herniotomy) was performed.Also, the patient suffers due to nerve root disorder due to this event.There was no issue with the cage; hence, the cage was re-implanted.The patient's issue is now resolved.The patient discharged from hospital.

• Brand Name: CLYDESDALE PTC SPINAL SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 8183474
• Report Number: 1030489-2018-01684
• Device Sequence Number: 11124593
• Product Code: MAX
• UDI-Device Identifier: 00643169190672
• UDI-Public: 00643169190672
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133205
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/20/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 4986250
• Device Lot Number: 69ER
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2018
• Initial Report FDA Received Date: 12/20/2018
• 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: Other; Required Intervention