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

Device Problems Patient-Device Incompatibility (2682); Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

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 to aesculap ag that an activ l (part # unknown) was implanted during a procedure performed on an unknown date.According to the complainant, the facet joints were failing on the implant.The patient will be undergoing a fusion revision surgery at level (l-4/5) where activ-l device was installed.The complaint device has not been returned to the manufacturer for evaluation.A revision surgery was necessary.An additional medical intervention was necessary.Although requested, additional information has not been made available.The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2022-00048(400543526 - ae-qas-sp44), 9610612-2022-00050(400543649 - ae-qas-sp44).

Manufacturer Narrative

Associated medwatch reports: 9610612-2022-00048.9610612-2022-00049.9610612-2022-00050.Updated - h6 codes.Investigation: up to now, products not provided.Therefore, no investigation possible.Batch history review: due to the fact that neither an article number nor a lot number was provided, a review of the device history records must remain incomplete.Explanation and rationale/conclusion and root cause: because there are no products and only minor information available, a definitive root cause analysis is not possible.Because the device history record is without any deviation, a material defect or manufacturing failure can be excluded.The following causes are possible: - wrong system configuration selected by the user.- wrong implant size chosen by the user.- end plate formed too strong by the user.- design layout unsuitable.- inadequate patient behavior.Corrective action: a capa is not necessary.

• Brand Name: COLLECT.NO.QAS SPINE SPINAL MOTION
• Type of Device: ACTIV L IMPLANTS
• 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: 13552713
• MDR Text Key: 286525241
• Report Number: 9610612-2022-00049
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Sex: Male