MAUDE Adverse Event Report: SYNTHES GMBH MANDIBLE-CORTSCR Ø2 SELF-TAP L10 TI; SCREW, FIXATION, INTRAOSSEOUS

Catalog Number 411.910

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 09/01/2022

Event Type  Injury  

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Device is not distributed in the united states, but is similar to device marketed in the usa.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported on (b)(6) 2022, that the patient implanted the orthognatic implants of the attached invoice in (b)(6) 2019.But 3 years after she presented a topical allergy (redness), that is, just outside, around the mouth region.The surgeon reported that the patient has allergy to nickel and chrome.The surgery for removal of the implants has already been performed and the patient did not present any metalosis in the region where the implants were and no apparent infection.This report is for one (1)mandible-cortscr ø2 self-tap l10 ti.This is report 8 of 16 for complaint (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.D10: therapy date is (b)(6) 2019.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Part: 411.910, lot: 9571902, manufacturing site: werk mezzovico, supplier: na, release to warehouse date: 16 jul 2015, expiration date: na.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device from the photo.Visual analysis of the photo revealed that there was no damage or defects with the mandible-cortscr ø2 self-tap l10 ti.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed for mandible-cortscr ø2 self-tap l10 ti.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h6: the device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10: additional narrative: a product investigation was completed: visual analysis of the returned sample revealed that there were no damage or defect with the device, only was observed signs of usage which could have been a result of implantation and explantation.In addition, the device presented no evidence of a device nonconformance a relation of the product with the reported adverse event.The source-controlled drawings reflecting the current and manufactured revisions were reviewed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the device was found to have no damage or defects.No definitive root cause could be determined.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: MANDIBLE-CORTSCR Ø2 SELF-TAP L10 TI
• Type of Device: SCREW, FIXATION, INTRAOSSEOUS
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15584024
• MDR Text Key: 301546382
• Report Number: 8030965-2022-08069
• Device Sequence Number: 1
• Product Code: DZL
• UDI-Device Identifier: 07611819030398
• UDI-Public: (01)07611819030398
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 411.910
• Device Lot Number: 9571902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 2.0 TI CHIN PL, DBLE BEND 5 H, 6 OFFSET; 2.4MM TI EMERGENCY SCREW 6MM-5PK; 2.4MM TI EMERGENCY SCREW 6MM-5PK; L-PL-2 LE 5HO TI; L-PL-2 LE 5HO TI; L-PL-2 R 5HO TI; L-PL-2 R 5HO TI; MANDIBLE-CORTSCR Ø2 SELF-TAP L12 TI; MANDIBLE-CORTSCR Ø2 SELF-TAP L12 TI; MANDIBLE-CORTSCR Ø2 SELF-TAP L12 TI; MF-CORTSCR Ø2 SELF-TAP L6 TI; MF-CORTSCR Ø2 SELF-TAP L6 TI; MF-CORTSCR Ø2 SELF-TAP L6 TI
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR
• Patient Sex: Female