MAUDE Adverse Event Report: AESCULAP AG ARCADIUS XP L IMPLANT 14° 29X40X18MM; SPINE SURGERY

Model Number	SO893P
Medical Device Problem Codes	Crack (1135); Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported that there was an issue with so878p: arcadius xp l implant 14° 25x35x18mm.According to the complaint description, the implant cracked.After fully seating the implant, two screws were successfully implanted in the top holes.A third was inserted in the bottom left (looking down at the patient) hole.The implant cracked on the front face upon final tightening of this screw, so the doctor opted to remove and replace the spacer.No additional intervention was required to retrieve the device beyond normal retrieval procedure, as the device stayed in one piece.There was a significant surgery delay.Additional information was not provided.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Correction: b5 - patient harm confirmed.Upon review of the investigation and confirmed patient harm, the product risk analysis (pra) was adjusted.The complaint is no longer considered to be reportable; severity is now decreased to 2(5).Investigation was previously submitted.
Event or Problem Description
Update: the patient harm was confirmed to be "surgical delay" and no other patient impact.
Event or Problem Description
Update: product updated to so893p - arcadius xp l implant 14° 29x40x18mm.The product was removed/retrieved; there was an additional medical intervention.This adverse event is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Corrected information - b1, b2, d4, (material, lot #, exp.Date, udi), h1.Investigation results: we made a microscopic investigation of the thread and the crack.Here we found, that the thread is damaged.Some of the plastic (peek) was squeezed off and pushed through the thread.Through the damaged thread and the squeezed material it came to inner tensions.Those tensions lead to a crack.Device 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 currently no further complaints with this lot and error pattern at hand.The current failure rate is within the risk analysis and therefore acceptable; severity was 3(5) and probability 3(5).Conclusion and preventive measures: the damaged thread and the crushed material caused internal tension.These stresses led to the crack.We cannot determine the cause of the damage to the thread.Based upon the investigation results, a capa is not necessary.

• Brand Name: ARCADIUS XP L IMPLANT 14° 29X40X18MM
• Common Device Name: SPINE SURGERY
• 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 gruen ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12535901
• Report Number: 9610612-2021-00636
• Device Sequence Number: 1271426
• Product Code: OVD
• UDI-Device Identifier: 04046964043918
• UDI-Public: 4046964043918
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K111122
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/29/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/08/2025
• Device Model Number: SO893P
• Device Catalogue Number: SO893P
• Device Lot Number: 52569920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2021
• Supplement Date Received by Manufacturer: 08/16/2023; 09/15/2023
• Initial Report FDA Received Date: 09/27/2021
• Supplement Report FDA Received Date: 09/14/2023; 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown