MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN CAGE/SPACER; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Device Problem Unintended Movement (3026)

Patient Problems Pain (1994); Hypoesthesia (2352); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that on an unknown date, the patient had surgery with concorde bullet lumbar interbody system and is clasping.The patient had the surgery done on (b)(6) 2019.The patient just learned how to walk with the walker and cane and still needs help in getting dressed.Revision surgery is needed by the patient by (b)(6) or sooner depends on whether the patient loses more mobility in the legs due to collapse and numbness.The patient's back hurt all the time, with its left side is numb from the left buttock down and around the front of the left leg.This complaint involves one (1) device.

Event Description

Patient was revised on (b)(6) 2019 because the device had collapsed.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information, which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.A review of the device history record (dhr) could not be performed, on the unknown cage/spacer.Product code: unk, lot number: unknown, quantity 1, since the lot number was not provided.Since this device(s) were not returned, no lot number could be taken directly from the device.Without the lot number, no review of its manufacturing records could be completed.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting per procedure (b)(4).Without the return of the device(s), we are unable to confirm, the reported issue or identify the root cause.No corrective action/preventive action (capa) is necessary at this time, as no issues were identified, in the manufacturing and release of this device(s) that could have contributed to the problem reported by the customer, since the lot number was not identified.Therefore, this complaint file will be closed.With no further action required.Should more information and/or the device(s)e become available at a later date, this complaint file will be reopened.And the device(s) will then receive a full evaluation.Device was used for treatment, not diagnosis.If information is obtained, that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.E1, e2.

• Brand Name: UNKNOWN CAGE/SPACER
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8826336
• MDR Text Key: 152191244
• Report Number: 1526439-2019-51883
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Public: (01)UNAVAILABLE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 46