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

Model Number	2991432
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2020
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 discectomy, laminectomy, and posterior fixation (intra-op).It was reported that the cage broke as it was inserted into the l5- s1 disc space.The fragment of the implant was removed from the patient.The implant broke and there was no fragment of the implant remaining in the patient's body.There were no patient symptoms or complications as a result of the event.The patient came in contact with the reported product as the implant was removed from the l51 disc space.The pre-op diagnosis was anterolisthesis, l4-5, gr i and retrolisthesis, l5-s1, gr i with hivd.The levels implanted were l5-s1.The cage was explanted on (b)(6) 2020.No further complications were reported/ anticipated.
Additional Manufacturer Narrative
Updated manufacturer information h3: product analysis part# 2991432, lot# h5608381- visual and optical inspection confirmed one of the ends of the spacer has been damaged and noticeable witness marks on both sides of the nose of the implant consistent with implanting and removing the implant.Microscopic examination revealed a very rigid fracture surface in multiple areas of the break.There is a crack that spreads from the middle to the top of the threaded attachment point.This type of damage appears to be consistent with bend stress overload during the implanting/removal process.H6: updated patient code, eval.Code method, and 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: 10654202
• Report Number: 1030489-2020-01403
• Device Sequence Number: 3219920
• Product Code: MAX
• UDI-Device Identifier: 00613994290908
• UDI-Public: 00613994290908
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 04/12/2021

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: 2991432
• Device Catalogue Number: 2991432
• Device Lot Number: H5608381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2020
• Supplement Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 10/09/2020
• Supplement Report FDA Received Date: 04/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR