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

Catalog Number	4986845
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	07/04/2018
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-operative diagnosis: spinal canal stenosis type of procedure: oblique lateral interbody fusion (olif) levels implanted: l4-l5 it was reported that on (b)(6) 2018, intra-op, the cage was attached to the sleeve inserter with tongue part, the protrusion part at the tip was engaged to tighten the screw, but although the cage should become fixed after being tightened as usual but it did not become fixed and seemed to idle, and the inserter could not hold the cage.There was a delay in overall procedure of less than 60 min as a result of this event.No patient complications were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis result: visual microscopic functional the threads of the implant are stripped.The direction of the thread damage is consistent with over tightening of 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: 7724403
• Report Number: 1030489-2018-01057
• Device Sequence Number: 920173
• Product Code: MAX
• UDI-Device Identifier: 00643169190535
• UDI-Public: 00643169190535
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133205
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/26/2025
• Device Catalogue Number: 4986845
• Device Lot Number: H5377834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2018
• Initial Date Received by Manufacturer: 07/04/2018
• Supplement Date Received by Manufacturer: 07/04/2018; 08/08/2018; 11/26/2018
• Initial Report FDA Received Date: 07/26/2018
• Supplement Report FDA Received Date: 07/26/2018; 10/03/2018; 12/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1