MAUDE Adverse Event Report: AESCULAP AG SSE 5.2 TI ROD 70MM; MPLANTS POSTERIOR STABILISATION

Model Number SX107T

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/05/2019

Event Type  Injury  

Manufacturer Narrative

Investigation results: the broken components were examined visually and microscopically.The rod is broken about 35 mm after the hexagon.We made a visual inspection of both fracture surfaces.There are clearly visible so called arrest lines, which are signs of a fatigue fracture on both parts.There are also little areas of secondary damages (metallic bright shining areas, caused by rubbing off the surfaces against another) visible.The fracture surface of both parts show no material or manufacturing abnormalities like blowholes or foreign material inclusions.Furthermore, especially the rod surface of part a shows material abrasion areas, which were caused due to loosening of the connection between the rod and the corresponding bracket.According to the information provided, the damage at part b is caused due to a drill in a first try to take out the rod.Unfortunately there are no information available about the patient and other external circumstances.Furthermore there are no x-ray figures available.Based on the information available as well as a result of our investigation, the root cause of the failure is most probably patient related/usage.Due to the fatigue fracture seen at analysis, and the visible material abrasions at the surface of the rod, it is apparent that the implant was exposed to micromovements.These micromovements, possibly coupled with high external load over an extended period of time, are likely to have lead to the breakage of the rod.No manufacturing relationship is established to the damage seen.The device quality and manufacturing history records have been checked for the available lot number and found to be according to our specification valid at the time of production.No similar incidents have been filed with products from this batch.

Event Description

It was reported that there was an issue with a broken sse rod- requiring explant.The following limited information was provided: the rod broke 13 years post-operative and an explantation was necessary.The implantation took place in 2006.About a year ago the patient felt pain and after several examinations the breakage of the rod was found.In a first try to take out the rod, the rod was damaged by a drill.In the end the explantation took place on (b)(6) 2019.No associated patient complications or adverse sequelae are reported.The adverse event is filed under aag reference (b)(4).

• Brand Name: SSE 5.2 TI ROD 70MM
• Type of Device: MPLANTS POSTERIOR STABILISATION
• 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: kerstin rothweiler ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8855394
• MDR Text Key: 153103396
• Report Number: 9610612-2019-00529
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K980484
• 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: 08/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SX107T
• Device Catalogue Number: SX107T
• Device Lot Number: 5517934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 55 YR