MAUDE Adverse Event Report: AESCULAP AG S4 POLYAXIAL SCREW 6.0X45MM; SPINE SURGERY

Model Number SW776T

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 03/11/2022

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with sw776t - s4 polyaxial screw 6.0x45mm.According to the complaint description, the revision surgery was 6 years 6.5 months post surgery due to fracture of implant.Initial surgery: (b)(6) 2015.The patient underwent t12-l4 arthrodesis for l2 fracture in 2015.Revision surgery: (b)(6) 2022.For 1 year, the patient had been developing low back pain.A spinal image showed bilateral l4 screw fracture.A revision surgery was necessary.Arthrodesis expansion was performed for l5-s1.The patient was recovering.The adverse event is filed under aesculap (b)(4) reference (b)(4).Involved components 400550458 - sw790t s4 set screw new version- lot 52125664.

Event Description

Involved components: 400550458 - sw790t s4 set screw new version - lot 52125664.

Manufacturer Narrative

Addtitional information: d9 - product return date investigation: we made visual inspection of the sw776t.In the first step we investigated the condition of the insert.Here we found no hints for a wrong applied rod like one-sided pressure marks.In the next step we investigated the fracture surface.Here we found the typically signs of a fatigue fracture.Additional we investigated the involved and enclosed set screw sw790t.Here we found on the bottom the wear pattern of a screw, which was correct tightened over an correctly applied (not tilted) rod.Batch history review: the device quality and manufacturing history records (dhr) have a 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.There are no similar complaints against the same lot number(s) with this error pattern.The review of risk assessment revealed that the overall risk level 4(5) severity x 2(5)probability of occurrence) according to din en iso 14971 is still acceptable.Explanation and rationale: without further knowledge about the circumstances, we assume, that the physical behavior and the bone-situation (stability, insufficient fusion of the bone) is the most probable root cause for the described problem.Conclusion and root cause: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.

• Brand Name: S4 POLYAXIAL SCREW 6.0X45MM
• Type of Device: 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 grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 14083985
• MDR Text Key: 289067943
• Report Number: 9610612-2022-00096
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K032219
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SW776T
• Device Catalogue Number: SW776T
• Device Lot Number: 52036686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2022
• Initial Date FDA Received: 04/12/2022
• Supplement Dates Manufacturer Received: 08/11/2022
• Supplement Dates FDA Received: 08/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2014
• 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
• Treatment: 1 (ONE) S4 SET SCREW - SW790T - BATCH: 52125664; SW790T S4 SET SCREW NEW VERSION - LOT 52125664
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female