MAUDE Adverse Event Report: MSD DEGGENDORF MFG CRESCENT SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number 9393007INT

Device Problem Break (1069)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/23/2020

Event Type  malfunction  

Manufacturer Narrative

Pma/510k: this part is not approved for use in the united states; however a like device catalog # 9393007, 510k # k172199, udi # (b)(4) was cleared in the united states.Foreign: (b)(6).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from healthcare professional via manufacturing representative regarding patient with spondylolisthesis suggested for l4/5 5/s transforaminal lumbar interbody fusion (tlif).Event occurred intra-op.It was reported that the cage broke when it was hit with hammer when inserting the cage.Device was not implanted.Status of fragments left in patient is unknown.Patient symptoms unknown.Device will be returned.No further complications reported.Update 2020-oct-23; after intervertebral disc curettage was performed with shaver, distractor 7mm was inserted into intervertebral disc.During expanding with tlif distractor, the reported cage was inserted.About 3 times, hammering was performed, about half of the cage went into the intervertebral space, the cage broke.Sr considered that there was no twist power being applied.The fragment was removed with forceps in the hospital (it is unknown whether all of them were removed).The intervertebral space was narrow.When the second one which was newly opened was inserted, expanding was performed with tlif distractor additionally, and it was inserted.Update 2020-oct-27; the operation was completed without problems, the patient was still in hospital.

Event Description

Information was received from healthcare professional via manufacturing representative regarding patient with spondylolisthesis suggested for l4/5 5/s transforaminal lumbar interbody fusion (tlif).Event occurred intra-op.It was reported that the cage broke when it was hit with hammer when inserting the cage.Device was not implanted.Status of fragments left in patient is unknown.Patient symptoms unknown.Device will be returned.No further complications reported.After intervertebral disc curettage was performed with shaver, distractor 7mm was inserted into intervertebral disc.During expanding with tlif distractor, the reported cage was inserted.About 3 times, hammering was performed, about half of the cage went into the intervertebral space, the cage broke.Sr considered that there was no twist power being applied.The fragment was removed with forceps in the hospital (it is unknown whether all of them were removed).The intervertebral space was narrow.When the second one which was newly opened was inserted, expanding was performed with tlif distractor additionally, and it was inserted.The operation was completed without problems, the patient was still in hospital.There was no malfunction with inserter product.The attachment of the inserter and implant had also been done according to surgical technique.

Manufacturer Narrative

Product analysis #262523981:9393007int lot # 56ed visual and macroscopic examination confirms the nose of the crescent implant where it interfaces with the inserter has broken off.M acroscopic examination of the lower implant revealed material deformation consistent with excessive force.Examination of the frac ture surface reveals a fairly brittle fracture surface, with rays emanating away from the area of crack propagation, and no indication of fatigue.The location and nature of the fracture, in addition to the implant nose damage is consistent with material overload during insertion as the mechanism of failure.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: CRESCENT SPINAL SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MSD DEGGENDORF MFG; wertstrasse 17; deggendorf 94469
• MDR Report Key: 10789971
• MDR Text Key: 214786666
• Report Number: 1030489-2020-01588
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9393007INT
• Device Catalogue Number: 9393007INT
• Device Lot Number: 56ED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Date Manufacturer Received: 04/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1