MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CAPSTONE PEEK VERT BODY SPACER; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	2990826
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	08/18/2020
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 a healthcare professional (hcp) via a medtronic representative regarding a patient implanted with a cage for a lumbar fusion.It was reported that the posterior third of the lumbar fusion cage was broken.The implant broke and there was no fragment of the instrument remaining in the patient's body.The fusion cage was broken during the surgery of the customer during implantation.The patient is associated with the event.There were no patient symptoms or complications as a result of the event.The pre- op diagnosis was a lumbar disc herniation.Details of levels implanted: in the first implantation, the surgeon hit the holder with a bone hammer.During the process of implanting the fusion cage, the fusion cage had not been completely implanted in the intervertebral space.There was no additional surgery or treatment performed.The product was explanted and replaced with a medtronic product.No further complications were reported/ anticipated.
Additional Manufacturer Narrative
D3: updated mfg site information h3: product analysis part# (b)(4), lot# h5537465- visual, optical- visual and optical inspection revealed the peek spacer was returned damaged.The threads have been stripped, corners have been deformed and rolled over and one side of the implant has been cracked.This type of damage is consistent with excessive force placed on the implant during the implantation process.H6: updated patient code, eval.Code method, eval.Code result post analysis 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: CAPSTONE PEEK VERT BODY SPACER
• 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 TN 00792
• MDR Report Key: 10527258
• Report Number: 1030489-2020-01267
• Device Sequence Number: 19597093
• Product Code: MAX
• UDI-Device Identifier: 00613994291035
• UDI-Public: 00613994291035
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K073291
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2021

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: 2990826
• Device Catalogue Number: 2990826
• Device Lot Number: H5537465
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2020
• Supplement Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 09/14/2020
• Supplement Report FDA Received Date: 01/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1