MAUDE Adverse Event Report: AESCULAP AG S4 ELEMENT POLYAXIAL SCREW 6.0X55MM; IMPLANTS POSTERIOR STABILISATION

Model Number ST266T

Device Problem Unintended System Motion (1430)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

It was reported to aesculap ag that a s4 element polyaxial screw 6.0x55mm (part # st266t) was used during a procedure performed on an unknown date.According to the complainant, the device disintegrated during surgery.During the operation, surgeon wanted to turn the head of the screw so that it was inserted into the patient and the screw "disintegrated", the inner sealing ring was loosened.The patient was not damaged, the surgeon had to remove the screw and use a new one.The complaint device was returned to the manufacturer for evaluation.An additional medical intervention was necessary.Additional information was not provided nor available.The adverse event is filed under aag reference (b)(4).Associated medwatch reports: 9610612-2021-00756 - 400526775 and 9610612-2021-00758 - 400527068.

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

Manufacturer Narrative

Investigation results/ visual investigation: a visual examination of the pedicle screws ("a" and "b") and their inlays was performed.No deviation to the specification was identified.The catches for both screws are in the correct position.The inner side of the screw heads showed no wear or signs of usage.Batch history review: there was no deviation to the specification.Conclusion and measures / preventive measures: the received screw shows no deviation to its specification.The complaint description could not be confirmed.Based upon the investigations results a capa is not necessary.

• Brand Name: S4 ELEMENT POLYAXIAL SCREW 6.0X55MM
• 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: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12920769
• MDR Text Key: 283771774
• Report Number: 9610612-2021-00756
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 04046963739294
• UDI-Public: 4046963739294
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: K090657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ST266T
• Device Catalogue Number: ST266T
• Device Lot Number: 52667461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2021
• 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