MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH CONCORDE BUL PAR 9X9X23; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	187823109
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Injury (2348); Blood Loss (2597); No Code Available (3191)
Date of Event	01/16/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported during an l4-5 minimally invasive transforaminal lumbar interbody fusion (tlif), the surgeon had increased bleeding while working in the interbody space.The pedicle screws on the contralateral side had already been placed and the screw holes were made on the ipsilateral (same) side of the tlif but had not been put in yet.The surgeon noticed a significant amount of bleeding while using the medtronic navigation probe in the disc space.It was controlled but oozing during the entire portion of the case.The probe had broken through the anterior portion of the disc space which could have led to the bleeding.An opal 10x28x8mm cage was placed by the surgeon, a rod then placed on the same side, and then they spun the o-arm which is a 3d image of the spine.The lateral image confirmed that the surgeon placed the cage too far anterior in the disc space so he attempted to remove the cage posteriorly.As he attempted this, he noticed increased blood loss so he decided to call a vascular surgeon to come in to assist.The patient was closed from the back, then flipped supine, and the vascular surgeons accessed the spine anteriorly to see what was causing the bleeding.They were able to remove the cage anteriorly as it was loose.They saw bone graft and gel foam anterior to the disc space and some damage to the inferior vena cava.They controlled the bleeding so then closed the patient anteriorly.Then, the patient was once again flipped prone and the surgeon reopened the incisions and proceeded with the tlif.He attempted to reposition a shorter concorde bullet 9x9x23mm cage into the disc space.The o-arm image that this cage was too far lateral to the disc space and too far anterior.He removed the cage with the cage inserted, and attempted to reinsert the cage multiple times.Every time showed that the cage was too far lateral and too far anterior to the disc space.Again, the cage was removed and left out of the patient.He instead packed the space with biologics which was also lateral to the disc space but decided to leave it, then put rods into the screws on both sides and locked them down.The surgeon then closed the patient¿s posterior incisions.Was surgery delayed due to the reported event? yes.If yes, number of minutes: 3 hours.Action taken when event occurred? yes.Was procedure successfully completed? yes.Were fragments generated? no.If yes, were they removed easily without additional intervention? unknown.If no, explain: no depuy synthes hardware fragments were generated.Patient status/ outcome / consequences: unknown.Patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)? increased blood loss, extra surgery.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required? yes.If yes, describe: extra surgery.Is the patient part of a clinical study? unknown.

• Brand Name: CONCORDE BUL PAR 9X9X23
• Common Device Name: 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: 8332480
• Report Number: 1526439-2019-51340
• Device Sequence Number: 46856
• Product Code: MAX
• UDI-Device Identifier: 10705034139340
• UDI-Public: (01)10705034139340
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K041722
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/16/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: 187823109
• Device Catalogue Number: 187823109
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2019
• Initial Report FDA Received Date: 02/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR