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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH 2.4MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 16MM; PLATE, BONE
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SYNTHES GMBH 2.4MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 16MM; PLATE, BONE Back to Search Results
Catalog Number 04.503.646.01S
Device Problem Crack (1135)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/29/2021
Event Type  malfunction  
Manufacturer Narrative
Additional narrative: this report is for an unk - screws: locking: mandible/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.Without a lot number the device history records review could not be completed.Product was not returned.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: (b)(4) reported as follows: on (b)(6) 2021 the primary fibular reconstruction procedure in the mandible was performed to treat ameloblastoma.Trumatch was applied without an issue.It was reported that, on jul.29 the patient underwent a revision procedure due to infection when the screw was removed during the revision procedure, a foreign metal substance like a torn screw thread was found.Procedure was completed successfully without any surgical delay.The surgeon commented the following: the patient¿s preoperative physical status was not fine.So, various/multiple causes might have been involved with the infection.The surgeon would like to know if the foreign substance might have triggered the infection or been one of the infectious causes.Severity of the event was ¿mild to moderate.¿ the patient is stable after the revision procedure.Note: both (b)(4) and this (b)(4) are interrelated.(b)(4) : about the revision procedure due to infection.(b)(4): about foreign substance found during the revision procedure.This report is for one (1) unk - screws: locking: mandible.This is report 1 of 1 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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
This report is for one (1) 2.4mm ti matrixmandible locking screw slf-tpng 16mm.
 
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 photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the photo.Visual analysis of the photo revealed that lock scr ø2.4 self-tap l16 tan 1u i/clip had a foreign metal substance surrounding it, as well as other unknown colored substances.However, the screw is undamaged.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 lock scr ø2.4 self-tap l16 tan 1u i/clip.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.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.
 
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Brand Name
2.4MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 16MM
Type of Device
PLATE, BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
Manufacturer (Section G)
SYNTHES MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12384672
MDR Text Key268701352
Report Number8030965-2021-07342
Device Sequence Number1
Product Code JEY
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K063790
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 08/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number04.503.646.01S
Device Lot Number103P135
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/23/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
CMD PATIENT SPECIFIC PLATE F/MANDIB MATM; LOCK SCR Ø2.4 SELF-TAP L12 TAN 1U I/CLIP; LOCK SCR Ø2.4 SELF-TAP L12 TAN 1U I/CLIP; LOCK SCR Ø2.4 SELF-TAP L14 TAN 1U I/CLIP; LOCK SCR Ø2.4 SELF-TAP L16 TAN 1U I/CLIP; LOCK SCR Ø2.4 SELF-TAP L16 TAN 1U I/CLIP; LOCK SCR Ø2.4 SELF-TAP L18 TAN 1U I/CLIP; LOCK SCR Ø2.4 SELF-TAP L8 TAN 1U I/CLIP; LOCK SCR Ø2.4 SELF-TAP L8 TAN 1U I/CLIP; LOCK SCR Ø2.4 SELF-TAP L8 TAN 1U I/CLIP; LOCK SCR Ø2.4 SELF-TAP L8 TAN 1U I/CLIP; LOCK SCR Ø2.4 SELF-TAP L8 TAN 1U I/CLIP; CMD PATIENT SPECIFIC PLATE F/MANDIB MATM; LOCK SCR Ø2.4 SELF-TAP L12 TAN 1U I/CLIP; LOCK SCR Ø2.4 SELF-TAP L12 TAN 1U I/CLIP; LOCK SCR Ø2.4 SELF-TAP L14 TAN 1U I/CLIP; LOCK SCR Ø2.4 SELF-TAP L16 TAN 1U I/CLIP; LOCK SCR Ø2.4 SELF-TAP L16 TAN 1U I/CLIP; LOCK SCR Ø2.4 SELF-TAP L18 TAN 1U I/CLIP; LOCK SCR Ø2.4 SELF-TAP L8 TAN 1U I/CLIP; LOCK SCR Ø2.4 SELF-TAP L8 TAN 1U I/CLIP; LOCK SCR Ø2.4 SELF-TAP L8 TAN 1U I/CLIP; LOCK SCR Ø2.4 SELF-TAP L8 TAN 1U I/CLIP; LOCK SCR Ø2.4 SELF-TAP L8 TAN 1U I/CLIP
Patient SexFemale
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