MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH COUGAR LS 18X8X55 LORDOTIC; INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR

Model Number	189155508
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j sales representative.Without a lot number the device history records review could not be completed.Customer quality investigation: the complaint device was not received for investigation.The following investigation is based on the image(s) provided.The image(s) was reviewed, and the complaint condition could be confirmed as it shows that the device is broken off but broken piece could not be seen in the image.Since the device was not returned, a dimensional inspection and a functional test were not able to be performed.A manufacturing record evaluation could not be performed as the lot number could not be determined from the image provided.A definitive assignable root cause could not be determined based on the provided information.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that during a spine procedure performed on (b)(6) 2020, a cage was broken on insertion and repositioning step.Fragments were generated but they were removed without additional interventions.There was a five (5) minutes surgical delay.The procedure was successfully completed.No patient consequences reported.Concomitant device reported: insertion instrument (part# unknown, lot# unknown, quantity unknown).This report is for one (1) cougar ls 18x8x55 lordotic.This is report 1 of 1 for (b)(4).
Additional 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: visual inspection: cougar ls 18x8x55 lordotic (part# 189155508, lot# unknown, qty# 1) was returned at us cq.Upon visual inspection at cq, it is observed that the device got broken into two pieces and the broken pieces were returned at cq.Thus, the complaint is being confirmed.Device failure / defect identified? yes.Dimensional inspection (calipers: ca215p): dimensional inspection of the received device was performed at cq due to post manufacturing damage.The thickness of the wall of the cage near the breakage was measured to be within specification as per the drawing.Documentation/ specification review: the following drawing(s) was reviewed: lateral cage lordotic 7mm-10mm height 45, 50, 55, 60, 65mm length.No design issues or discrepancies were found during this investigation.Complaint confirmed? yes.Investigation conclusion: the complaint is being confirmed for cougar ls 18x8x55 lordotic (part# 189155508, lot# unknown) as the device was received broken at cq.While a definitive root cause could not be identified for the reported problem, it is possible that the device might have encountered unintended forces.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based upon these results, no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot: a manufacturing record evaluation could not be performed as the lot number could not be determined from the image provided.No mre was performed as the lot number is unknown.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.

• Brand Name: COUGAR LS 18X8X55 LORDOTIC
• Common Device Name: INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 11205034
• Report Number: 1526439-2021-00171
• Device Sequence Number: 2140823
• Product Code: MAX
• UDI-Device Identifier: 10705034165387
• UDI-Public: (01)10705034165387
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K173787
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2020

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: 189155508
• Device Catalogue Number: 189155508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2021
• Initial Date Received by Manufacturer: 12/23/2020
• Supplement Date Received by Manufacturer: 02/03/2021
• Initial Report FDA Received Date: 01/20/2021
• Supplement Report FDA Received Date: 02/22/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN INSERTION INSTRUMENTS