COLLECT.NO.QAS SPINE SPINAL MOTION AE-QAS-SP44

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-27 for COLLECT.NO.QAS SPINE SPINAL MOTION AE-QAS-SP44 manufactured by Aesculap Ag.

Event Text Entries

[186210507] Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10


[186210508] It was reported that there was an issue with an active l implant. It was noted that during the original implantation of the activl device, the surgeon was not able to get direct alignment with the midline due to limited exposure. Postoperatively , the patient complained of leg pain after 5 month. The x-ray results showed that the implant had migrated to the left side off the midline which caused back pain. It was noted that the patient was not involved in any extraneous activity; however, the patient was smoking and not following proper procedure. The explant surgery was postponed due to the patient 's "non-compliant" behavior. The revision surgery was delayed indefinitely. Additional information was requested. The adverse event is filed under aag reference (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610612-2020-00051
MDR Report Key9889832
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-27
Date of Report2020-03-27
Date of Event2020-03-10
Date Mfgr Received2020-03-10
Date Added to Maude2020-03-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer ContactMS KERSTIN ROTHWEILER
Manufacturer StreetPO BOX 40
Manufacturer CityTUTTLINGEN, 78501
Manufacturer CountryGM
Manufacturer Postal78501
Manufacturer G1AESCULAP AG
Manufacturer StreetPO BOX 40
Manufacturer CityTUTTLINGEN, 78501
Manufacturer CountryGM
Manufacturer Postal Code78501
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCOLLECT.NO.QAS SPINE SPINAL MOTION
Generic NameACTIV L IMPLANTS
Product CodeMJO
Date Received2020-03-27
Model NumberAE-QAS-SP44
Catalog NumberAE-QAS-SP44
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerAESCULAP AG
Manufacturer AddressPO BOX 40 TUTTLINGEN, 78501 GM 78501


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2020-03-27

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