MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS ACTIV C TRIAL IMPLANT FLAT SIZE S 5MM; INSTRUMENTS SPINAL MOTION

Model Number FW791R

Device Problem Material Integrity Problem (2978)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 06/13/2019

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: the implant arrived in a decontaminated condition.At first sight one marker dome is seen "chipped off".The broken part is not provided.Investigation - the components were examined microscopically with the digital microscope vhx-5000 keyence eq.Nr.(b)(4).A visual examination was made of the instrument and its damage.The fracture surface shows no hints of material abnormalities.The other dome exhibits small impacts, most probably caused during surgery.The broken off xray marker dome was not available for investigation.Batch history review - this product does not require batch management; a review of device history quality and manufacturing history records is not possible.Conclusion and root cause - based on the information available, as well as our investigation, the root cause of the failure is most probably usage related.Rationale - there are no hints of a material or manufacturing problem.It is possible that the damage was caused by mechanical overload situation (too rough handling / too high force applied during surgery).According to sop (b)(4) a capa is not necessary.

Event Description

It was reported that the surgeon performed the "prosthesis test" and decided it was the correct one for this patient.It was removed from the patient and the intervertebral space was cleaned.During the cleaning procedure, the surgeon noticed a foreign body in the surgical field.It was later determined to be a piece of the trial device that had been removed.The piece was successfully removed and no associated patient complications or adverse sequelae are reported.No other details provided.

• Brand Name: ACTIV C TRIAL IMPLANT FLAT SIZE S 5MM
• Type of Device: INSTRUMENTS SPINAL MOTION
• Manufacturer (Section D): AESCULAP IMPLANT SYSTEMS; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: kerstin rothweiler ; am aesculap-platz; tuttlingen, badden-wurttemberg 78532 ; GM 78532
• MDR Report Key: 8801977
• MDR Text Key: 151410376
• Report Number: 9610612-2019-00462
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FW791R
• Device Catalogue Number: FW791R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2017
• 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