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

Catalog Number	5011227
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the r eported event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Date of initial surgery: (b)(6) 2018.Type and level of initial surgery: l5- s1 transforaminal lumbar interbody fusion (tlif).Pre-operative diagnosis: compression of the nerve.It was reported that intra-operatively the spacer was broken while performing rotation.The thread was broken and unable to attached again.The device come in contact with the patient.Procedure was completed with another new cage.Patient complications were unknown with the available information.The product was inserted into the intervertebral space and rotation was performed.The thread was broken and unable to gripped.The new cage was opened to complete the procedure.The tip of inserter become widened.
Additional Manufacturer Narrative
Product analysis result: visual function microscopic the spacer was returned with torsional deformation on the back side that interfaces with the inserter.There is some damage to the threaded hole.The hole as became oblong at the top from a bending moment passed through the inserter.The threads have visible damaged but were still able to be threaded to the inserter.There are witness marks inside the spacer recesses indicating torsional force.The damage to the spacer appears to be the result of torsional overload.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CAPSTONE CONTROL PTC
• 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
• MDR Report Key: 7632773
• Report Number: 1030489-2018-00897
• Device Sequence Number: 19221349
• Product Code: MAX
• UDI-Device Identifier: 00643169677593
• UDI-Public: 00643169677593
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2018

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 Catalogue Number: 5011227
• Device Lot Number: H5400562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2018
• Initial Date Received by Manufacturer: 05/25/2018
• Supplement Date Received by Manufacturer: 09/20/2018
• Initial Report FDA Received Date: 06/24/2018
• Supplement Report FDA Received Date: 10/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1