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U.S. Department of Health and Human Services

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

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AESCULAP IMPLANT SYSTEMS ARCADIUS XP L IMPLANT 9° 25X35X14MM; SPINAL IMPLANT Back to Search Results
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.
 
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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 Key5992243
MDR Text Key56100774
Report Number3005673311-2016-00153
Device Sequence Number1
Product Code OVD
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K111122
Number of Events Reported1
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 Date01/31/2021
Device Model NumberSO844P
Device Catalogue NumberSO844P
Device Lot Number52196674
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/02/2016
Distributor Facility Aware Date09/02/2016
Device Age7 MO
Initial Date Manufacturer Received 08/29/2016
Initial Date FDA Received09/30/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/19/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
SO872P / ARCADIUS XP L IMPLANT 14° 25X35X12MM
Patient Outcome(s) Other;
Patient Age46 YR
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