MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS ARCADIUS XP L IMPLANT 9° 29X40X12MM; NTERBODY FUSION

Model Number SO857P

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Blood Loss (2597)

Event Date 08/11/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.Device not returned.

Event Description

Country of complaint: usa.It is was reported that the right lateral surface of the arcadius implant gripped the lateral disc annulus upon insertion and pulled a vein, which was attached to the lateral annulus, into the disc space with the cage.Vascular surgeon was immediately called in to assess the vein and the cage was removed, exposing a tear in the vein.Vascular repaired the tear, during which the patient lost an estimated 2l of blood.The case was delayed approximately 1 hour for the repair.The surgeon opted to utilize the smaller footprint graft upon continuation of the case with no further incidents.Occurred during l5-s1 alif(anterior lumbar interbody fusion) surgery.Patient lost an estimate 2 liters of blood.Surgical delay of 1 hour for the repair of the vein.

Manufacturer Narrative

Investigation: no product is at hand.Batch history review: the manufacturing documents have been checked and found to be according to specification valid during the time of production.Conclusion and root cause: the root cause of the problem is most probably usage related.Rational: according to the dhr, the product was manufactured without any deviation to its specification (no sharp edges e.G.).This is the first complaint with such a problem over the entire product family.No capa is necessary.

• Brand Name: ARCADIUS XP L IMPLANT 9° 29X40X12MM
• Type of Device: NTERBODY FUSION
• Manufacturer (Section D): AESCULAP IMPLANT SYSTEMS; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 6811924
• MDR Text Key: 83313471
• Report Number: 9610612-2017-00434
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111122
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: SO857P
• Device Catalogue Number: SO857P
• Device Lot Number: 52134505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/18/2017
• Device Age: 2 YR
• Date Manufacturer Received: 08/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other