MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH COUGAR LS LATERAL CAGE SYSTEM LORDOTIC CAGE 18 X 14 X 50MM, 15 DEGREES; INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR

Model Number	189150614
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/ or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.(b)(4).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
It was reported that on an unknown date, the cage broke during impaction into hard bone where the space was extremely collapsed.Screws were later inserted to back up the interbody fusion and the screwdrivers stripped during final tightening attempting to back out the screws and adjust the height.No fragments were generated.The cage will stay implanted.The surgeon packed the rest of the space with bone.Procedure was successfully completed with no surgical delay.There was no patient consequences.Concomitant device reported: unknown impaction instruments (part # unknown, lot # unknown, quantity unknown), unknown insertion instruments (part # unknown, lot # unknown, quantity unknown).This report is for one (1) cougar ls lateral cage system lordotic cage 18 x 14 x 50mm, 15 degrees.This is report 1 of 5 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: investigation summary: complaint summary it was reported that on an unknown date, the cage broke during impaction into hard bone where the space was extremely collapsed.Screws were later inserted to back up the interbody fusion and the screwdrivers stripped while final tightening and also while attempting to back out the screws to adjust the height.No fragments were generated.The cage will stay implanted.The surgeon packed the rest of the space with bone.Procedure was successfully completed with no surgical delay.There was no patient consequences.Concomitant device reported: unknown impaction instruments (part# unknown, lot# unknown, quantity unknown ).Unknown insertion instruments (part# unknown, lot# unknown, quantity unknown ).This complaint involves five (5) devices.The device was not returned.A photo-investigation was performed on the image.A broken cage implant was observed; fragments were not visible in the image.No other issues were noted.No device identifiers were visible.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.Conclusion: the complaint condition was confirmed during photo investigation.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive 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.
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: 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.D11: concomitant product added to complaint.H3, h4, h6: part number:338.31, synthes lot number: 7287833, supplier lot number: n/a, release to warehouse date: 12mar2013, expiration date: n/a, manufactured by synthes jennersville.No ncrs were generated during production.Investigation summary: complaint summary it was reported that on an unknown date, the cage broke during impaction into hard bone where the space was extremely collapsed.Screws were later inserted to back up the interbody fusion and the screwdrivers stripped while final tightening and also while attempting to back out the screws to adjust the height.No fragments were generated.The cage will stay implanted.The surgeon packed the rest of the space with bone.Procedure was successfully completed with no surgical delay.There was no patient consequences.Concomitant device reported: unknown impaction instruments (part# unknown, lot# unknown, quantity unknown ).Unknown insertion instruments (part# unknown, lot# unknown, quantity unknown ).This complaint involves five (5) devices the device was not returned.A photo-investigation was performed on the image.A broken cage implant was observed; fragments were not visible in the image.No other issues were noted.No device identifiers were visible.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.Conclusion: the complaint condition was confirmed during photo investigation.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive 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.
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.H10 additional narrative: a broken cage implant was observed; fragments were not visible in the image.No other issues were noted.No device identifiers were visible.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The complaint condition was confirmed during photo investigation.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive 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.

• Brand Name: COUGAR LS LATERAL CAGE SYSTEM LORDOTIC CAGE 18 X 14 X 50MM, 15 DEGREES
• 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: 10860795
• Report Number: 1526439-2020-02219
• Device Sequence Number: 14535315
• Product Code: MAX
• UDI-Device Identifier: 10705034356815
• UDI-Public: (01)10705034356815
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 189150614
• Device Catalogue Number: 189150614
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/23/2020
• Supplement Date Received by Manufacturer: 11/20/2020; 12/17/2020; 01/26/2021; 03/21/2021; 05/13/2021
• Initial Report FDA Received Date: 11/18/2020
• Supplement Report FDA Received Date: 11/24/2020; 01/11/2021; 01/29/2021; 04/14/2021; 05/13/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COUGAR LS 18X14X50 15-DEG LORD; REDUCTION SHAFT; REDUCTION SHAFT; T20 SCREWDRIVER SHAFT; T20 SCREWDRIVER SHAFT; T20 SCREWDRIVER SHAFT; UNKNOWN IMPACTION INSTRUMENTS; UNKNOWN IMPACTION INSTRUMENTS; UNKNOWN IMPACTION INSTRUMENTS; UNKNOWN INSERTION INSTRUMENTS; UNKNOWN INSERTION INSTRUMENTS; UNKNOWN INSERTION INSTRUMENTS; VIPER2 FINAL TIGHTENER DRIVER; VIPER2 FINAL TIGHTENER DRIVER; VIPER2 SCREW EXTENSION, OPEN; VIPER2 SCREW EXTENSION, OPEN; X25 FINAL TIGHTENER; X25 FINAL TIGHTENER; X25 FINAL TIGHTENER; X25 FINAL TIGHTENER; X25 FINAL TIGHTENER; X25 FINAL TIGHTENER; X25 FINAL TIGHTENER; X25 FINAL TIGHTENER; X25 FINAL TIGHTENER; X25 FINAL TIGHTENER; T20 SCREWDRIVER SHAFT; UNKNOWN IMPACTION INSTRUMENTS; UNKNOWN INSERTION INSTRUMENTS; X25 FINAL TIGHTENER; X25 FINAL TIGHTENER
• Outcome Attributed to Adverse Event: Required Intervention