MAUDE Adverse Event Report: AESCULAP AG S4 ELEMENT POLYAXIAL SCREW 6.0X60MM; IMPLANTS POSTERIOR STABILISATION

Model Number	ST267T
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported to aesculap ag that a s4 element polyaxial screw 6.0x60mm (part # st267t) was used during a procedure performed on an unknown date.According to the complainant, during the procedure, the surgeon wanted to turn his head 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.Although requested, additional information has not been made available.The adverse event is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Investigation results/ visual investigation: we made a visual inspection of the pedicle screw and its inlay.Here we found no deviation to the specification.Both catches are in their correct position (fig.2&3).The inner side of the head shows no wear or signs of usage batch history review: due to the investigation results, that no deviation is founded, a batch history records was not made.Conclusion and measures / preventive measures: on the basis of the available information as well as the investigation results the product is without an error.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results a capa is not necessary.

• Brand Name: S4 ELEMENT POLYAXIAL SCREW 6.0X60MM
• Common Device Name: 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: 12924032
• Report Number: 9610612-2021-00757
• Device Sequence Number: 20030614
• Product Code: NKB
• UDI-Device Identifier: 04046963739300
• UDI-Public: 4046963739300
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: K090657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2021

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
• Operator of Device: Health Professional
• Device Model Number: ST267T
• Device Catalogue Number: ST267T
• Device Lot Number: 52559947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2021
• Supplement Date Received by Manufacturer: 12/03/2021
• Initial Report FDA Received Date: 12/03/2021
• Supplement Report FDA Received Date: 12/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown