MAUDE Adverse Event Report: ZIMVIE US CORP LLC GENTEK¿ ANGULATED SCREW CHANNEL TIBASE, TSV®/TM¿ ENGAGING, 4.5MMD X 1.3MMCH; DENTAL TIBASE

Catalog Number	ZFX11ZB-TSV45AS13E
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Doctor reported that the titnium bases at tooth sites 36 and 46 fractured by the screw part and were removed.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).D10: concomitant medical product: zfx11zb-tsv45as03e, gentek¿ angulated screw channel tibase, tsv®/tm¿ engaging, 4.5mmd x 0.3mmch, lot: 0000250218.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).The following fields have been updated: b4: date of this report.B5: describe event or problem.D4: unique identifier (udi) number.G3: date received by manufacturer.G6: type of report.H1: type of reportable event.H2: follow up type.H3: device evaluated by manufacturer.H4: device manufacturer date.H6: adverse event problem.H11: additional narrative.Zfx received one (1) gentek® angulated screw channel tibase, tsv®/tm® engaging, 4.5mmd x 1.3mmch, and the associated screw one (1) gentek® hexalobular retaining screw, tsv®/tm® , for evaluation.Visual evaluation / functional test was performed.-visual evaluation: the screw is broken right at the start of the thread.The screw has visual damages because of the use.Screw is full of cement on all sides including the initial end of the threat.Broken thread has not been received.Ti base has the hex broken and is also full of cement.-functional test: the screwhead is in good condition and it can be turned with screwdriver.The ti-base is broken, and no functional test is possible complaint history review was performed for the reported lot number l000251112 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿screw fracture¿.Complaint history review was performed for the reported lot number l000251112 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿abutment fracture¿.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was excessive torque applied - customer error.Therefore, based on the available information, a device malfunction did occur.Screw and tibase are broken.The reported event was confirmed.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.
Event or Problem Description
Doctor reported that one ti base fracture at the hex and the screw, and other screw fractured.Tooth sites 36 and 46.

• Brand Name: GENTEK¿ ANGULATED SCREW CHANNEL TIBASE, TSV®/TM¿ ENGAGING, 4.5MMD X 1.3MMCH
• Common Device Name: DENTAL TIBASE
• Manufacturer (Section D): ZIMVIE US CORP LLC; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMVIE US CORP LLC; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: mark mashburn ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 24092701
• Report Number: 0001038806-2026-00318
• Device Sequence Number: 10468660
• Product Code: NHA
• UDI-Device Identifier: 04251881714685
• UDI-Public: (01)04251881714685(10)0000251112(240)ZFX11ZB-TSV45AS13E
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K231915
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: ZFX11ZB-TSV45AS13E
• Device Lot Number: 0000251112
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 12/30/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/16/2026
• Supplement Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DENTAL TI BASE SEE H10 NARRATIVE
• Patient Age: 40 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic