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

Catalog Number	4986255
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/28/2019
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
Pre-operative diagnosis: spondylolisthesis procedure: oblique lumbar interbody fusion (olif) level implanted: l4/5 it was reported that intra-op, the physician prepared a cage of a bigger size and inserted the bigger cage inside the patient's body, but because there was cage in the same position as the position where installed the original cage, the bigger cage was removed too.The thread part of the bigger cage broke.Additionally, surgery performed because cage insertion by olif approaching failed so posterior lumbar interbody fusion with posterior approaching was performed.The product came in contact with the patient.No patient symptoms or complication were reported as result of this event.
Additional Manufacturer Narrative
Product analysis results: optical and microscopic examination of the implant returned for analysis identified deformation at the inserter mating face and threads are damaged.This is consistent with significant impact during attempted implantation.If information is provided in the future, a supplemental report will be issued.

• 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: 8367904
• Report Number: 1030489-2019-00194
• Device Sequence Number: 11241543
• Product Code: MAX
• UDI-Device Identifier: 00643169190665
• UDI-Public: 00643169190665
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2019

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: 4986255
• Device Lot Number: H5419957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2019
• Initial Date Received by Manufacturer: 01/28/2019
• Supplement Date Received by Manufacturer: 06/19/2019
• Initial Report FDA Received Date: 02/25/2019
• Supplement Report FDA Received Date: 07/19/2019
• 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