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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CRESCENT SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
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MDT SOFAMOR DANEK PUERTO RICO MFG CRESCENT SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR Back to Search Results
Model Number 9393010
Device Problem Material Fragmentation (1261)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 11/06/2020
Event Type  malfunction  
Manufacturer Narrative
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a health care professional via manufacturer representative regarding a spacer used in lumbar decompression intervertebral fusion and internal fixation.Pre-operative diagnosis for this procedure was lumbar canal stenosis.It was reported that after the fusion was implanted in the intervertebral space.Only part of it was removed after it was broken, and the remaining part of the fusion was still in the patient's body.No patient symptoms reported.No further complications were reported.
 
Event Description
Information was received from a health care professional via manufacturer representative regarding a spacer used in lumbar decompres sion intervertebral fusion and internal fixation.Pre-operative diagnosis for this procedure was lumbar canal stenosis.It was reported that after the fusion was implanted in the intervertebral space.Only part of it was removed after it was broken, and the remaining part of the fusion was still in the patient's body.No patient symptoms reported.No further complications were reported.Updated information received on (b)(6) 2020.During the implantation process of the fusion device, the fracture occurred when turning and knocking.The fusion device was not replaced after the rupture occurred.Since the rest of the device in the body was relatively intact and was not taken out, the surgery was completed directly.The doctor didn't know the specific reason, and it had nothing to do with the use or use of the combined equipment during the surgery.The patient is currently in good condition and has been discharged from hospital.
 
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.
 
Manufacturer Narrative
H3: product analysis #: (b)(4), lot#: h5619211.Only one small portion of the implant returned for analysis (~8mm).Microscopic fracture surface examination identified rays emanating from the one corner of the implant surface.The above observations are consistent with brittle 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.
 
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Brand Name
CRESCENT SPINAL SYSTEM
Type of Device
INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
Manufacturer (Section D)
MDT SOFAMOR DANEK PUERTO RICO MFG
barrio marianna rd 909, km0.4
humacao PR 00792
MDR Report Key10926157
MDR Text Key218971568
Report Number1030489-2020-01717
Device Sequence Number1
Product Code MAX
UDI-Device Identifier00613994187628
UDI-Public00613994187628
Combination Product (y/n)N
PMA/PMN Number
K094025
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 02/16/2021
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
Device Operator Health Professional
Device Model Number9393010
Device Catalogue Number9393010
Device Lot NumberH5619211
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/08/2021
Initial Date Manufacturer Received 11/12/2020
Initial Date FDA Received12/01/2020
Supplement Dates Manufacturer Received12/03/2020
02/11/2021
Supplement Dates FDA Received12/21/2020
02/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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