MAUDE Adverse Event Report: SYNTHES GMBH 2.0 TI CHIN PL, DBLE BEND 5 H, 6 OFFSET; PLATE, BONE

Model Number	447.074
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	09/01/2022
Type of Reportable Event	Serious Injury
Additional 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.Additional narrative: 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 or Problem Description
Device report from synthes reports an event in brazil as follows: it was reported on (b)(6) 2022, that the patient implanted the orthognatic implants of the attached invoice in july 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)2.0 ti chin pl, dble bend 5 h, 6 offset.This is report 12 of 16 for complaint (b)(4).
Additional 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.
Additional 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.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Part:447.074, lot:h522288, manufacturing site: werk selzach, supplier: (b)(4), release to warehouse date:20 dec 2017, 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 2.0 ti chin pl, dble bend 5 h, 6 offset.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 2.0 ti chin pl, dble bend 5 h, 6 offset.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.
Additional 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.

• Brand Name: 2.0 TI CHIN PL, DBLE BEND 5 H, 6 OFFSET
• Common Device Name: PLATE, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach CO 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15584227
• Report Number: 8030965-2022-08074
• Device Sequence Number: 20429562
• Product Code: JEY
• UDI-Device Identifier: 10887587052694
• UDI-Public: (01)10887587052694
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K021642
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup

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?: No
• Operator of Device: Health Professional
• Device Model Number: 447.074
• Device Catalogue Number: 447.074
• Device Lot Number: H522288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2022
• Supplement Date Received by Manufacturer: 09/23/2022; 11/10/2022; 02/22/2024
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 11/02/2022; 12/02/2022; 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/20/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 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 L10 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 25 YR
• Patient Sex: Female