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

Catalog Number	5011022
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/08/2019
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: lumbar spinal canal stenosis level implanted: l4-5 procedure: posterior lumbar interbody fusion (plif) it was reported that intra-op, cage was placed in the intervertebral disc space and rotated but the cage did not rotate so it was removed.When removing the holder, surgeon checked the image and found that the screw itself did not rotate.Surgeon hurriedly attached the handle and removed the cage.The removed cage was deformed.The product came in contact with the patient.There was a delay of more than 60 minutes as a result of this event.Patient complications were reported unknown.
Additional Manufacturer Narrative
Product analysis results: visual and microscopic inspection revealed significant torsional/twisting deformation to the body of the implant.The threads that connect the spacer to the inserter have been stripped.It appears the threads were overloaded during the installation process.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CAPSTONE CONTROL 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: 8390502
• Report Number: 1030489-2019-00224
• Device Sequence Number: 1431986
• Product Code: MAX
• UDI-Device Identifier: 00643169677500
• UDI-Public: 00643169677500
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171107
• 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
• Report Date (Section B): 05/24/2019

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 Catalogue Number: 5011022
• Device Lot Number: H5413588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2019
• Initial Date Received by Manufacturer: 02/08/2019
• Supplement Date Received by Manufacturer: 05/08/2019
• Initial Report FDA Received Date: 03/05/2019
• Supplement Report FDA Received Date: 05/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1