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

Device Problem Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

Event Description

It was reported that there was an issue with ae-qas-sp44 - collect.No.Qas spine spinal motion.According to the complainant, the implant experienced an issue with "function." post-operative images revealed that the implant was in flexion where it has remained since.The physician attributed this to the patient's diminished, if not absent, muscle tone in the lumbar region.The complaint device was not available to be returned to the manufacturer for evaluation.No further patient information has been made available.Although requested, additional information has not been made available.The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2021-00540 (400522138 - ae-qas-sp44), 9610612-2021-00552 (400522402 - ae-qas-sp44), 9610612-2021-00553 (400522403 - ae-qas-sp44).

• Brand Name: COLLECT.NO.QAS SPINE SPINAL MOTION
• Type of Device: IMPLANTS SPINAL MOTION
• 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: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12333351
• MDR Text Key: 266958393
• Report Number: 9610612-2021-00540
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2021
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Other