MAUDE Adverse Event Report: LDR MÉDICAL ROI-C CAGE; POLYMERE SPINE FUSION CAGE, STERILE

Model Number N/A

Device Problems Break (1069); Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/20/2019

Event Type  Injury  

Manufacturer Narrative

This medwatch is submitted to send the initial report.From information provided by the reporter, 3 cages broken during surgery.Only for 2 products the references and lot numbers for cages and anchoring plate were provided.For the third cage/anchoring plates, the reference and lot number are not known.Additional information was requested.Investigation still on going.Conclusion not yet available.Device not returned yet.

Event Description

Roi-c: 3 broken cages during surgery, delay 60 mins.From information provided by the reporter, 3 cages broke during a surgery.First cage : roi-c cage was inserted in patient.During plate insertion the cage cracked.Surgeon removed cage.New cage was inserted.Second cage : the surgeon used the starter awls, then first and second anchoring plate.After visual inspection, the cage cracked.The surgeon removed cage using burr.Third cage: the surgeon inserted the cage, awl, then plates.After implantation, the surgeon noticed that the cage cracked in same corners as previous.Fourth cage : the surgeon inserted the cage, awl, then plates.Upon inspection cage looked intact.Surgeon closed.No known impact on patient.The surgery was delayed 60 minutes due to removal of 3 cages.Investigation on going.

Event Description

Roi-c : 3 broken cages during surgery, delay 60 mins.From information provided by the reporter, 3 cages broked during a surgery.First cage : roi-c cage was inserted in patient.During plate insertion the cage cracked.Surgeon removed cage.New cage was inserted.Second cage : the surgeon used the starter awls, then first and second anchoring plate.After visual inspection, the cage cracked.The surgeon removed cage using burr.Third cage : the surgeon inserted the cage, awl, then plates.After implantation, the surgeon noticed that the cage cracked in same corners as previous.Fourth cage : the surgeon inserted the cage, awl, then plates.Upon inspection cage looked intact.Surgeon closed.No known impact on patient.The surgery was delayed 60 minutes due to removal of 3 cages.Additional information received on march 21th 2019 : product will return.The cage was properly assembled with the holder.The axis of the disc space was respected.Surgical technique were respected for anchoring plate impaction sequence (use of impactor #1 then impactor #2).First anchoring plate was fully seated.It is not possible that two anchors were implanted in the same slot.One level was implanted.No x-rays will be provided.The issue occurred in implantation of the second anchoring plate.Patient had sclerotic bone.No more information is available.

Manufacturer Narrative

This medwatch is submitted to send the result of the investigation of this complaint.Without a product return, no product evaluation is able to be conducted.Review of traceability and review of the device history records did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.Additional information was requested but after several attempts, no reply was received.From the information provided, the product history records, the review of the case with the product manager and the recurrence of this type of event for this product, the investigation found no evidence to indicate a device related issue.The root cause is unknown but probably related to patient hard bones.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Manufacturer Narrative

Additional information received on march 21th 2019 : product will return.The cage was properly assembled with the holder.The axis of the disc space was respected.Surgical technique were respected for anchoring plate impaction sequence (use of impactor #1 then impactor #2).First anchoring plate was fully seated.It is not possible that two anchors were implanted in the same slot.One level was implanted.No x-rays will be provided.The issue occurred in implantation of the second anchoring plate.Patient had sclerotic bone.Further information were requested.Investigation still on going.Conclusion not yet available.

Event Description

Roi-c : 3 broken cages during surgery, delay 60 mins.From information provided by the reporter, 3 cages broke during a surgery.First cage : roi-c cage was inserted in patient.During plate insertion the cage cracked.Surgeon removed cage.New cage was inserted.Second cage : the surgeon used the starter awls, then first and second anchoring plate.After visual inspection, the cage cracked.The surgeon removed cage using burr.Third cage : the surgeon inserted the cage, awl, then plates.After implantation, the surgeon noticed that the cage cracked in same corners as previous.Fourth cage : the surgeon inserted the cage, awl, then plates.Upon inspection cage looked intact.Surgeon closed.No known impact on patient.The surgery was delayed 60 minutes due to removal of 3 cages.Additional information received on march 21th 2019 : product will return.The cage was properly assembled with the holder.The axis of the disc space was respected.Surgical technique were respected for anchoring plate impaction sequence (use of impactor #1 then impactor #2).First anchoring plate was fully seated.It is not possible that two anchors were implanted in the same slot.One level was implanted.No x-rays will be provided.The issue occurred in implantation of the second anchoring plate.Patient had sclerotic bone.Investigation on going.

• Brand Name: ROI-C CAGE
• Type of Device: POLYMERE SPINE FUSION CAGE, STERILE
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• MDR Report Key: 8436131
• MDR Text Key: 139318180
• Report Number: 3004788213-2019-00087
• Device Sequence Number: 1
• Product Code: OVE
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 05/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: NO INFORMATION
• Device Lot Number: NO INFORMATION
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 58 YR