MAUDE Adverse Event Report: AESCULAP AG ARCADIUS XP L IMPLANT 9° 29X40X10MM; MPLANTS INTERBODY FUSION

Model Number SO855P

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 01/19/2016

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: evaluation on-going.Device not returned.

Event Description

Country of complaint: (b)(6).According to surgeon a relation to procedure of the medical device cannot be excluded.The segment l5-s1 was additionally stabilized by an internal fixation.The corrective measure was taken on (b)(6) 2016.

• Brand Name: ARCADIUS XP L IMPLANT 9° 29X40X10MM
• Type of Device: MPLANTS 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: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 5694500
• MDR Text Key: 46385766
• Report Number: 3005673311-2016-00086
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• 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: 06/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2018
• Device Model Number: SO855P
• Device Catalogue Number: SO855P
• Device Lot Number: 51950861
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/20/2016
• Date Manufacturer Received: 05/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2013
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other