MAUDE Adverse Event Report: DEPUY SPINE INC COUGAR LS 18X14X50 15-DEG LORD; INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR

Model Number	189150614
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional product code: mqp.Complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 on (b)(6) 2021, the patient underwent for a surgery.During the surgery, the cougar ls cage cracked on impaction.Also, second implant cracked on impaction.In this time, the implant broke small fragment off and remaining cage was not removed.The surgery was completed.There was no patient consequence.Concomitant device reported: unknown impaction instrument (part# unknown, lot# unknown, quantity unknown).Unknown insertion instrument (part# unknown, lot# unknown, quantity unknown).This complaint involves (2) devices.This report is for (1) cougar ls 18x14x50 15-deg lord.This report is 1 of 2 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: h3, h6: a product investigation was conducted.Visual inspection: the cougar ls 18x14x50 15-deg lord (p/n: 189150614, lot number: 512319) was received at us cq.Upon visual inspection the complaint device was observed to be broken and the broken fragments were not returned.No other issues were observed with the complaint device.Dimensional inspection: a relevant dimensional inspection was not able to perform due to the device geometry document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed.No design issues or discrepancies were identified.Investigation conclusion: this complaint is confirmed as the device was received broken.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that 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.H3, h4, h6: a device history record (dhr) review was conducted: a manufacturing record evaluation was performed for the finished device product code: 189150614.Lot number: 512319.It was electronically reviewed and no non-conformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 02.02.2016.Qty: (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 also reported that the second implant also cracked on impaction.The device cracked around the area beneath the inserter connection.The surgeon felt the integrity of the remaining large cage in the disc space would be more than sufficient.

• Brand Name: COUGAR LS 18X14X50 15-DEG LORD
• Common Device Name: INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive ; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 13122165
• Report Number: 1526439-2021-02679
• Device Sequence Number: 4518224
• Product Code: MAX
• UDI-Device Identifier: 10705034356815
• UDI-Public: (01)10705034356815
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K122896
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup

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: 189150614
• Device Catalogue Number: 189150614
• Device Lot Number: 512319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/02/2021
• Supplement Date Received by Manufacturer: 01/19/2022
• Initial Report FDA Received Date: 12/30/2021
• Supplement Report FDA Received Date: 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COUGAR LS 18X14X50 15-DEG LORD; UNKNOWN IMPACTION INSTRUMENTS; UNKNOWN INSERTION INSTRUMENTS
• Patient Sex: Unknown