MAUDE Adverse Event Report: AESCULAP AG ACTIV L INF.PLATE SIZE M 0°/SPIKES; SPINE SURGERY

Model Number	SW980K
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported that an activ l inf.Plate size m 0°/spikes (part # sw980k) was to be used during a procedure performed on (b)(6) 2021.According to the complainant, after opening the implant, the surgeon observed very poor machining as well as a very small piece of material on the inlay surface.The implant was exchanged for another and then the procedure was continued and successfully completed.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the event.Additional information was not provided nor available / was not available.Additional information has been requested but not yet received as of this report.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Additional information/correction: g4 - 510k h6 - codes updated upon review of the investigation, no product error was found.The complaint was re-assessed and is no longer considered to be reportable.Investigation results: the implant arrived in an incomplete cardboard- box and opened primary-blister within.During the first inspection, we found no particles.We sent the implant to the im manufacturing plant for examination.Topic 1: poor editing marks: the milling grooves outside the calotte are within the drawing specification, so this does not represent a deviation.The surface the dome is also within specification.With the error, no detailed statement can be made from the description.Issue 2: very small piece of material on surface: during the investigation we didn't find any foreign bodies, particles or anything like that.This feature is 100% visually inspected before the packaging process.There are no indications in the production order and the device history record dhr as to which would have led to this error pattern.Device history review: the device quality and manufacturing history records (dhr) have been checked for all leading device(s) lot numbers and the products found to be according to our specification valid at the time of production no failure detected and therefore the sub-items of "statistical analysis" cannot be applied.Conclusion and preventive measures: the implant shows neither particles nor unacceptable defects on the surface.If there were actually any particles on the surface of the implant, then they were probably lost during transport.Based upon the investigation results, a capa is not necessary.

• Brand Name: ACTIV L INF.PLATE SIZE M 0°/SPIKES
• Common Device Name: SPINE SURGERY
• 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 gruen ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12760853
• Report Number: 9610612-2021-00698
• Device Sequence Number: 4326771
• Product Code: MJO
• UDI-Device Identifier: 04038653425815
• UDI-Public: 4038653425815
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P120024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/05/2025
• Device Model Number: SW980K
• Device Catalogue Number: SW980K
• Device Lot Number: 52610701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2021
• Supplement Date Received by Manufacturer: 09/25/2023
• Initial Report FDA Received Date: 11/07/2021
• Supplement Report FDA Received Date: 10/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown