MAUDE Adverse Event Report: AESCULAP AG COLLECT.NO.QAS SPINE SPINAL MOTION; SPINE SURGERY

Model Number AE-QAS-SP44

Device Problem Misassembly by Users (3133)

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

Event Date 05/17/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: investigation on-going.

Event Description

It was reported that there was an issue with the activl artificial disc system.The implants consist of 3 components that are put together.It was reported via the enhanced safety surveillance survey that the a device dis-assembled during surgery in one instance.The surgeon noted that the insertion tools needed more secure fixation to the device.This report was a cumulative review of the devices based on the surgeon's 1-2 year experience using the implant system and was relevant from 01feb2018- 31jan2019 timeframe.The surgeon has reportedly performed a total of 12 surgeries; five procedures at l4-l5, four procedures at l5-s1, and twelve procedures using spike endplates.The reporter stated that patients who have been implanted with the activl artificial disc system did not require more than a standard pain medicine protocol post-surgery; that standard pain management consisted of physical therapy.It was additionally noted that there have been no other safety concerns; the physician stated that l5-s1 procedures showed better outcomes than l4-l5.Overall, patient outcomes following activl artificial disc implantation showed improved range of motion, stability, and neurological status.They also experienced improved back pain relief and improved disability and that patients return to work within the expected timeframe most of the time.Intervention was not required and no patient harm occurred.Additional information has been requested.

Manufacturer Narrative

Manufacturing evaluation : no product at hand.Therefore an investigation is not possible.There are no pictures available.Batch history review : because the lot number is unknown, a batch history review is not possible.Conclusion and root cause : due to the circumstance that we did not receive the complained devices for investigation and lack of information, it is not possible to determine a definitive conclusion and root cause for the mentioned failure.Rationale : because there are no products and only minor information available, a definitive root cause analysis is not possible.Following causes are possible: wrong system configuration selected by user; wrong implant size chosen by user; end plate formed too strong; design layout unsuitable; inadequate patient behavior.No capa necessary.

• Brand Name: COLLECT.NO.QAS SPINE SPINAL MOTION
• Type of Device: SPINE SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8701827
• MDR Text Key: 148168213
• Report Number: 9610612-2019-00402
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• PMA/PMN Number: P120024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AE-QAS-SP44
• Device Catalogue Number: AE-QAS-SP44
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/17/2019
• Date Manufacturer Received: 08/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1