MAUDE Adverse Event Report: AESCULAP AG QUINTEX CONSTRAINED SCREW 4.5X17MM; SPINE SURGERY

Model Number	SC493T
Medical Device Problem Codes	Compatibility Problem (2960); Mechanical Jam (2983)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2022
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 that there was an issue with sc493t-quintex constrained screw 4.5x17mml.According to the complainant, the quintex screw was not locking into the plate.It also would not back out and a screw removal instrument was used to lift the plate out with the screw still in it.This occurred during a revision anterior cervical discectomy fusion (acdf) procedure.An additional medical intervention was required.The surgery was delayed by about 45 minutes.It was noted that the surgery was successful after a longer plate was implanted.Additional patient information is not available.The adverse event / malfunction is filed under aag reference (b)(4).Involved components: sc512t - 22 mm plate; sc403t - constrained screw 4/16mm.
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 that there was an issue with sc493t-quintex constrained screw 4.5x17mml.According to the complainant, the quintex screw was not locking into the plate.It also would not back out and a screw removal instrument was used to lift the plate out with the screw still in it.This occurred during a revision anterior cervical discectomy fusion (acdf) procedure.An additional medical intervention was required.The surgery was delayed by about 45 minutes.It was noted that the surgery was successful after a longer plate was implanted.Additional patient information is not available.The adverse event / malfunction is filed under aag reference (b)(4).Involved components: sc512t - 22 mm plate; sc403t - constrained screw 4/16mm.
Additional Manufacturer Narrative
Additional information/correction: b5 - type of event; lot number for involved component.D4 - lot number.D9 - product return date.D10 - involved component lot number.H3 - evaluation.H4 - manufacture date.H6 - codes updated.Investigation results: we made a visual inspection of the screw and the plate in their incoming (in- screwed) condition.Except slight wear marks we found no damages or deformation.We then took the removal tool provided for such cases and tried to unscrew the screw according to the instructions.The surgical technique brochure notes specific points to observe in the case.Device history review: the device quality and manufacturing history records have 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 currently no further complaints with this lot and error pattern at hand.The current failure rate is within the risk analysis and therefore acceptable as per procedures; severity was 2(5) and probability 2(5).Conclusion/preventive measures: the root cause for the problem is handling related.The screw could be removed easily and without any further damage following the steps explained in the instructions.Based upon the investigation results, a capa is not required.
Event or Problem Description
The adverse event is filed under aag reference (b)(4).Involved components: (b)(4) - quintex hybrid plate 1-level 22mm - lot 52638103.(b)(4) - quintex constrained screw 4.0x16mm - lot unknown.

• Brand Name: QUINTEX CONSTRAINED SCREW 4.5X17MM
• Common Device Name: 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 gruen ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 13487095
• Report Number: 9610612-2022-00013
• Device Sequence Number: 20145395
• Product Code: KWQ
• UDI-Device Identifier: 04046963814137
• UDI-Public: 4046963814137
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K100243
• 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): 10/25/2023

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: SC493T
• Device Catalogue Number: SC493T
• Device Lot Number: 52625707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2022
• Supplement Date Received by Manufacturer: 10/12/2023
• Initial Report FDA Received Date: 02/08/2022
• Supplement Report FDA Received Date: 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SC403T; SC403T - LOT UNKNOWN; SC512T; SC512T - LOT 52638103
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown