MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON® FENESTRATED SCREW SET; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	55851025550
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other: revision surgery is scheduled.The following screws were reported: product #: 55851025545, lot#: unknown, quantity: 2; product #: 55851025550, lot#: unknown, quantity: 2.It is unknown which two screws from the reported screws were broken.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare professional via manufacturer representative regarding a patient having percutaneous trauma stabilization for t12 burst fracture.Levels implanted: t11-l1 it was reported that the screws shanks broke under tulip.1-month post-operative, the surgeon reported that 1 screw had broken, at 3 months follow up 2 screws had broken.Removal of screws and fusion is scheduled to happen in the next 2 weeks due to broken screws and loss of correction.Patient symptoms are unknown.No further complications were reported regarding the event.Additional information was received that only 2 screws broke and it is unknown which screws broke.
Additional Manufacturer Narrative
Additional information: a1, a4, b5, d6b, g3, h6, additonal codes medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
All items are explanted and replaced.Potentially, it was hard to say if the screws broke because of the non-union, or if it was the broken screws that contributed to the non-union.Both are probably correct.From the x-rays it appears to be these two screws were broken, at the shank, just under the tulip.
Additional Manufacturer Narrative
H3: product analysis #705106029: part # 55851025550, lot # h5612964 visual review confirmed screw breakage approximately 2 threads down from the base of the bone screw neck.Visual and optical examination of the area of fracture initiation did not identify a pre-existing surface defects that could contribute to crack propagation.Some fracture surface smearing is noted.Microscopic examination of the fracture surface revealed s small area of fatigue lines and the rest of the surface is damaged too much to analyze.This type of damage is consistent with cyclic fatigue.Additional information: d4 medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CD HORIZON® FENESTRATED SCREW SET
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer (Section G): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 15201655
• Report Number: 1030489-2022-00750
• Device Sequence Number: 11290460
• Product Code: NKB
• UDI-Device Identifier: 00763000143763
• UDI-Public: 00763000143763
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K201362
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 55851025550
• Device Catalogue Number: 55851025550
• Device Lot Number: H5612964
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2022
• Supplement Date Received by Manufacturer: 08/10/2022; 01/18/2023
• Initial Report FDA Received Date: 08/10/2022
• Supplement Report FDA Received Date: 09/08/2022; 01/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 70 KG