MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS ARCADIUS XP L IMPLANT 14° 25X35X14MM; IMPLANTS INTERBODY FUSION

Model Number SO874P

Device Problem Crack (1135)

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

Event Date 12/01/2016

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: usa.It was reported that the surgeon was placing a medial screw at l5/s1 in the arcadius xp device when it cracked after he tightened it.He noticed it immediately, and then distracted the disc space and removed the device completely from the patient.No harm to the patient.There was a 2 minute delay in surgery.Components in use listed as concomitant devices are: so874p / arcadius xp l implants 14 25x35x14mm; sj01t / a-space sibd bone screw 4.5x25mm; sj02t / a-space sibd screw 4.5x30mm.

Manufacturer Narrative

Investigation: the implant arrived in a clean state without visible damage.The components have been examined visually and microscopically with a keyence vhx-5000 digital microscope and a panasonic dmc tz8 digital camera.We found that the initial thread was damaged.Batch history review: the manufacturing documents have been checked and found to be according to specification valid during the time of production.Conclusion and root cause: the root casue of the problem is most probably user related.Rational: there are no hints of pre-damage or similar.We assume through the damaged initial thread that a slantingly attached screw as the causal factor.A material defect can be excluded.No capa is necessary.

• Brand Name: ARCADIUS XP L IMPLANT 14° 25X35X14MM
• Type of Device: IMPLANTS INTERBODY FUSION
• Manufacturer (Section D): AESCULAP IMPLANT SYSTEMS; 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: 6211527
• MDR Text Key: 63732992
• Report Number: 9610612-2016-00014
• Device Sequence Number: 1
• Product Code: OVD
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SO874P
• Device Catalogue Number: SO874P
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/15/2016
• Date Manufacturer Received: 12/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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: SJ01T / A-SPACE SIBD BONE SCREW 4.5X25MM; SJ702T / A-SPACE SIBD SCREW 4.5X30MM; SO874P / ARCADIUS XP L IMPLANT 14 25X35X14MM
• Patient Outcome(s): Other