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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 8MM; BONE PLATE

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SYNTHES GMBH 2.4MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 8MM; BONE PLATE Back to Search Results
Catalog Number 04.503.638.01S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Increased Appetite (4570)
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4).Additional narrative: complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 jul.29, 2021, the patient underwent for a revision surgery due to infection.On (b)(6) 2021 the primary fibular reconstruction procedure in the mandible was performed to treat ameloblastoma.Trumatch was applied without surgical delay.It was unknown if the revision surgery completed successfully.The patient outcome unknown.No further information is available.This complaint involves twelve (12) devices.This report is for (1) 2.4mm ti matrixmandible locking screw slf-tpng 8mm.This report is 7 of 12 for (b)(4).Related product 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.H4, h6: product code: 04.503.638.01s, lot number: 80p1388, manufacturing site: bettlach, release to warehouse date: 07 december 2020, expiry date: 01 november 2030.A manufacturing record evaluation was performed for the finished device lot and no non-conformance was identified.Product was not returned.Based on the information available, it has been determined that no corrective and 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.
 
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Brand Name
2.4MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 8MM
Type of Device
BONE PLATE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
Manufacturer (Section G)
WERK BETTLACH (CH)
muracherstrasse 3
bettlach 2544
SZ   2544
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12387861
MDR Text Key268996469
Report Number8030965-2021-07352
Device Sequence Number1
Product Code JEY
UDI-Device Identifier07611819939851
UDI-Public(01)07611819939851
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 Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/02/2021
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? No
Device Operator Health Professional
Device Catalogue Number04.503.638.01S
Device Lot Number80P1388
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/02/2021
Initial Date FDA Received08/30/2021
Supplement Dates Manufacturer Received11/08/2021
Supplement Dates FDA Received11/15/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/07/2020
Is the Device Single Use? Yes
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
Patient Outcome(s) Required Intervention;
Patient SexFemale
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