MAUDE Adverse Event Report: AESCULAP AG ARCADIUS XP L IMPLANT 4° 25X35X14MM; IMPLANTS INTERBODY FUSION

Model Number SO814P

Device Problem Material Split, Cut or Torn (4008)

Patient Problems Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/30/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with so814p - arcadius xp l implant 4° 25x35x14mm.According to the complaint description, the cage split during impaction in an anterior lumbar interbody fusion (alif) procedure.The inserter was tight to the cage and the cage was being inserted in a superior to downward inferior angle into l5-s1.There was a delay of about 3 minutes required to retrieve the broken piece and open a new cage.The adverse event is filed under aag reference (b)(4).

Event Description

Update: an additional medical intervention was required.The piece was retrieved.

Manufacturer Narrative

Investigation: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Batch history review: the device quality and manufacturing history records (dhr) have been checked for all leading device(s) lot numbers and the products found to be according to our specification valid at the time of production.There are no similar complaints against the same lot number(s) with this error pattern.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material, manufacturing- or design-related failure.Based upon the investigation results, a capa is not necessary.

• Brand Name: ARCADIUS XP L IMPLANT 4° 25X35X14MM
• Type of Device: IMPLANTS INTERBODY FUSION
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12359542
• MDR Text Key: 271511495
• Report Number: 9610612-2021-00575
• Device Sequence Number: 1
• Product Code: OVD
• UDI-Device Identifier: 04046964043604
• UDI-Public: 4046964043604
• 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: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SO814P
• Device Catalogue Number: SO814P
• Device Lot Number: 52630676
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2020
• 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): Required Intervention