MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS ARCADIUS XP L IMPLANT 9° 25X35X14MM; SPINAL IMPLANT

Model Number SO844P

Device Problem Break (1069)

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

Event Date 08/29/2016

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: the implant arrived broken and in a decontaminated condition.A microscopic investigation of the threads and fracture surface was completed.It was discovered the thread was damaged.Some of the plastic was compressed through the thread and formed a chip.Through the damaged thread and the compressed material caused inner tension which resulted in a crack of the material.The manufacturing documents were reviewed and found to be according to specification valid during the time of production.The root cause is a damage to the thread of the implant, which can be caused by: the implant screws being applied cross threaded.The bone not being properly prepared.Based on the information available as well as a result of the investigation, root cause of the failure is most probably user related.The implants do not exhibit any manufacturing or material problems.The manufacturing documents are without any deviation.Corrective/preventive action is not required.

Event Description

Country of complaint: (b)(6).During surgery when the cage was inserted it broke.The surgery was prolonged for more than 15 minutes.Involved component filed as concomitant medical product: so872p / arcadius xp l implant 14 deg 25x35x12mm, batch number: 52199356, manufacture date: 02/05/2016 expiration date: 01/31/2021.

• Brand Name: ARCADIUS XP L IMPLANT 9° 25X35X14MM
• Type of Device: SPINAL IMPLANT
• Manufacturer (Section D): AESCULAP IMPLANT SYSTEMS; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP IMPLANT SYSTEMS; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 5992243
• MDR Text Key: 56100774
• Report Number: 3005673311-2016-00153
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K111122
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: SO844P
• Device Catalogue Number: SO844P
• Device Lot Number: 52196674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2016
• Distributor Facility Aware Date: 09/02/2016
• Device Age: 7 MO
• Initial Date Manufacturer Received: 08/29/2016
• Initial Date FDA Received: 09/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2016
• 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
• Treatment: SO872P / ARCADIUS XP L IMPLANT 14° 25X35X12MM
• Patient Outcome(s): Other
• Patient Age: 46 YR