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

Model Number	2968250
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from regulatory body regarding a cage used for olif.It was reported that on (b)(6) 2022, at about 14:45 in the 6th operating room, when the doctor was performing olif operation on the last lumbar vertebra(lumbar 2/3), medtronic manufacturer found that it could not hold the fusion cage.After careful inspection and comparison, the instrument was missing three clips, each of which was about 1*3mm in size.The itinerant nurses immediately began to search, the surgeons washed their hands, the nurses, and the equipment manufacturers immediately searched in the surgical field and sterile equipment table, but failed.So the visiting nurse reported to the foreman and head nurse.The three clamping pieces holding fusion device were shaken off due to heavy force in the initial use process. finally, one clip was found in the bottle cap of the aspirator, and the other two pieces were not found.The chief surgeon also washed the incision several times.Repeated c-arm photography during the operation could not find it.Finally, surgeon asked the radiology department to take a bedside film to confirm that it was not in the patient.Then the incision was closed and the patient returned safely.  during the operation, repeated c-arm shooting and searching, and closed the incision after the bedside shooting of radiology department confirmed that it was not in the patient's body. there was the possibility of residual instruments, increased the c-arm photographic examination, and prolonged the operation time.There were no patient symptoms or complications reported as a result of this event.Additional information received from manufacturer representative that there were no fragment of the implant or instrument remaining in the patient.Preoperative diagnosis was lumbar disc herniation.Product came in contact with the patient.There were no patient symptoms or complications reported as a result of this event.There was a delay in the surgery, but less than 1 hour.There were no additional surgical or medical intervention done as a result of this event.
Additional Manufacturer Narrative
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: CLYDESDALE¿ SPINAL SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,
• 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: 14840469
• Report Number: 1030489-2022-00587
• Device Sequence Number: 11922179
• Product Code: MAX
• UDI-Device Identifier: 00613994485809
• UDI-Public: 00613994485809
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K083026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/28/2022

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: 2968250
• Device Catalogue Number: 2968250
• Device Lot Number: H5692688
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2022
• Initial Report FDA Received Date: 06/28/2022
• Date Device Manufactured: 07/01/2021
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Male