MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON X10 CROSSLINK; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	8110530
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from healthcare professional via field representative regarding patient with screw deviation involved in the l5 screw replacement.Levels implanted- l2-l5.It was reported that intra-operatively, tip of the driver broke.No fragments left in the patient's body.An attempt was made to remove the prolock first to replace the screw, but the golden set screw of the prolock stripped one place.They removed the set screws of ps on both sides and removed the prolock along with the rod.After the screw replacement was completed, the original implanted rod and prolock were reset, and when the prolock was finally fixed with a 3.0mm hex driver according to the manual max, tip of the driver broke.The broken driver tip was removed using an air tome.There was delay in overall procedure time for less than 60 minutes.Event was revision surgery to explant the deviated screw.Initial surgery procedure was plif of 3 intervertebral discs at l2-l5.There were no patient symptoms or complications reported as a result of this event.No health damage in the patient was reported.On (b)(6) 2021, received additional information that, it was an operation for replacement since the deviation of the screw inserted in the initial operation was confirmed.Two crosslinks were used, one of them had set screw stripping on one side.Therefore, all eight set screws of the pedicle screws were removed, and the rod was removed with the crosslink connected.After reinserting (reusing) the screw on the right side of l5, reusing and placing the rod and crosslink, a new set screw of the pedicle screw was used and finally tightened.On 2021-sep-21, received additional information that the l5 right screw was deviated.The screw was re-used to treat the patient in the revision surgery.One of the crosslinks which was implanted in the primary surgery had set screw stripping on one side during removal in the revision surgery.It was re-used to treat the patient.
Additional Manufacturer Narrative
H3: device evaluated summary- visual and optical examination identified that the tip of the hex driver has been sheared off, consistent with interface during usage and was not returned for analysis.Material hardness tested and was found to be within specification.This is consistent with overload.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 X10 CROSSLINK
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 12615836
• Report Number: 1030489-2021-01268
• Device Sequence Number: 16497646
• Product Code: LXH
• UDI-Device Identifier: 00721902744600
• UDI-Public: 00721902744600
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2022

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 Model Number: 8110530
• Device Catalogue Number: 8110530
• Device Lot Number: KH15K284
• 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: 09/16/2021
• Supplement Date Received by Manufacturer: 03/24/2022
• Initial Report FDA Received Date: 10/12/2021
• Supplement Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female