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

Catalog Number	4986045
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/29/2017
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
It was reported that the patient was pre-operatively diagnosed with spondylolisthesis at l3/4, l4/5 and underwent oblique lumbar interbody fusion.Intra-op, the fragments of the peek was attached on the inserter thread part after inserting the cage.The cage could not be grasped and was loose so the inserter was checked carefully.Patient complications reported to be unknown.
Additional Manufacturer Narrative
Product analysis: visual examination showed that the two small silvers of peek material have been returned it appears this two pieces came from the inserter being threaded into the implant.The whole implant was not returned.Since this happen twice this could have been the result of some damage to the inserter.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: 7141501
• Report Number: 1030489-2017-02543
• Device Sequence Number: 1237996
• Product Code: MAX
• UDI-Device Identifier: 00643169190733
• UDI-Public: 00643169190733
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2018

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 Expiration Date: 07/07/2025
• Device Catalogue Number: 4986045
• Device Lot Number: H5359579
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2018
• Initial Date Received by Manufacturer: 11/29/2017
• Supplement Date Received by Manufacturer: 04/12/2018
• Initial Report FDA Received Date: 12/22/2017
• Supplement Report FDA Received Date: 05/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1