MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC PIVOX OBLIQUE LATERAL SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	2140010
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2020
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 provider via field representative regarding instrument involved in oblique lateral interbody fusion (olif) procedure at l2 and l3.It was reported that during procedure, threaded tip broke off during placement of implant.Reported instrument broke and they were used quite frequently.They completed the procedure with back up sets that was available.Reported, they were able to remove the tip out of the instrument with needle nose pliers.So, there were no fragments left in the patient.There was delay in procedure for about 30 minutes total.There were no patient symptoms or complications reported as a result of the event.Patient is alive and no injury.
Additional Manufacturer Narrative
Additional information: d9, h3, h6.H3: device evaluation summary: visual and optical inspection revealed the instrument is damaged around the inserter attachment area.The edges have been rolled over and deformed along with multiple witness marks consistent with impacts from a hammer.This type of damage is consistent with material overload from multiple impacts.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: PIVOX OBLIQUE LATERAL SPINAL SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 10502294
• Report Number: 1030489-2020-01235
• Device Sequence Number: 3182214
• Product Code: MAX
• UDI-Device Identifier: 00643169639522
• UDI-Public: 00643169639522
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K152277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2020

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: 2140010
• Device Catalogue Number: 2140010
• Device Lot Number: NM15M0981
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2020
• Supplement Date Received by Manufacturer: 11/18/2020
• Initial Report FDA Received Date: 09/08/2020
• Supplement Report FDA Received Date: 11/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1