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

Catalog Number	2991232
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: visual and optical inspection revealed the peek implant has been damaged.Optical examination confirmed the upper threads had been stripped.This type of damage is consistent with misalignment of the driver during the attachment process.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient underwent l5-s1 herniation decompression and internal fixation.Intra-op, thread slipping was observed at the interface of the threaded fusion cage.The product came in contact with the patient.There were no patient symptoms or complications as a result of this event.

• Brand Name: CAPSTONE 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: 9511932
• Report Number: 1030489-2019-01464
• Device Sequence Number: 10867923
• Product Code: MAX
• UDI-Device Identifier: 00613994290946
• UDI-Public: 00613994290946
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K073291
• 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
• Report Date (Section B): 12/23/2019

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: 2991232
• Device Lot Number: H5534660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2019
• Initial Report FDA Received Date: 12/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR