MAUDE Adverse Event Report: AESCULAP AG S4 SET SCREW CANULATED; IMPLANTS POSTERIOR STABILISATION

Model Number SW375T

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Pain (1994); Joint Disorder (2373)

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: the implants arrived in decontaminated condition.Investigation: used test- and analysis- equipment: microscope "keyence- vhx 5000 " eq.-nr.2000024840 digital-camera "panasonic dmc tz8" first we made a visual inspection of the set screws "a" and "b".The hexagon of the screws exhibit no damages.In the next step we investigated the bottom of the screws.The bottom of both screws exhibits the typically wear of a not proper tightened screw, respectively a screw who was tightened over a not correct placed rod.The stripe disposed wear on the bottom of both screws are hints for a moving rod during the backing out of the screw.The inlay of the both enclosed pedicle screws is shown.At one edge of both screws a strong wear is visible.This was caused by a not proper (tilted) inserted rod.A sample ct of a tilted inserted rod is shown.It is clearly visible, that the rod contacts the insert of one screw only at the edge batch history review: the manufacturing documents have been checked and found to be according to specification valid during the time of production.There are no further complaints with this lot at hand.Conclusion and root cause: the root cause for the problem is most probably usage related.Rationale: the wear shapes on the bottom of the set screws and in the inserts are sure hints for tightening with a not correct (tilted) applied rod.A material failure or a manufacturing error can be excluded.The ifu points out to check the position of the rod at / in the insert of the pedicle screw during insertion and before tightening the set screw: corrective action: according to sop (b)(4) (corrective action & preventive action) a capa is not necessary.

Event Description

It was reported that there was an issue with an s4 set screw.According to the reporter the patient complained of a "squeaky back".An x-ray showed that there was a locking nut next to the screw.During surgery, however, it was shown that both locking nuts were next to the screws.A revision surgery was performed on (b)(6) 2020 an additional medical intervention was necessary.Additional patient information is not available.The adverse event is filed under aag reference (b)(4).Involved components: sw347t - s4 polyaxial screw 6.5x50mm canulated - 52487327.Sw375t - s4 set screw canulated - 52523204.

• Brand Name: S4 SET SCREW CANULATED
• Type of Device: IMPLANTS 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: 9786341
• MDR Text Key: 182307266
• Report Number: 9610612-2020-00031
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K062085
• 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: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SW375T
• Device Catalogue Number: SW375T
• Device Lot Number: 52523204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2019
• 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