MAUDE Adverse Event Report: BIOMET 3I TSX IMPLANT, 3.1MMD, 8MML; DENTAL IMPLANT

Catalog Number	TSX31B8
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Doctor reported that in the last order they received there were some implants with a cracked cap.Doctor noticed at the time of surgery and implants were changed by distributor for new ones.No patient impact.
Additional Manufacturer Narrative
Zimvie complaint number cmp (b)(4).A1: patient identifier unknown / not provided.A2: age at time of the event unknown / not provided.A3: gender unknown / not provided.A4: patient weight unknown / not provided.B3: date of event unknown / not provided.D10.Concomitant medical products.Tsvb10, impl tapered scr-v sbm 3.7mm 3.5mm 10mm, lot 1261974.Tsvb11, impl tapered scr-v mtx 3.7mm 3.5mm 11.5mm lot 1264279.Tsx31b8, tsx implant, 3.1mmd, 8mml lot 1261974.Tsv4b10, imp,tsv,4.1mm,sbm,10 lot 1261280.Tsv4b11, imp,tsv,4.1mm,sbm,11.5 lot 1262306.Tsv4b13, imp,tsv,4.1mm,sbm,13 lot 1260099.Tsvb11, impl tapered scr-v mtx 3.7mm 3.5mm 11.5mm lot 1264279 x 4.Tsvb11, impl tapered scr-v mtx 3.7mm 3.5mm 11.5mm lot 1260333 x 2.Tsv4b11, imp,tsv,4.1mm,sbm,11.5 lot 1262306 x 2.D10.Therapy date unknown.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimvie complaint number: (b)(4).The following fields have been updated: b4: date of this report.B5: describe event or problem.G3: date received by manufacturer.G6: type of report.H1: type of reportable event.H2: follow up type.H3: device evaluated by manufacturer.H6: adverse event problem.H10: additional narrative.Zimvie received one (1) tsx31b8, (tsx implant, 3.1mmd, 8mml) for evaluation.Visual evaluation of the as returned device identified the implant outer packaging was already opened.The implant outer vial has a cracked blue cap, and the outer vial tamper seal was intact.The coob is confirmed.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.This complaint refers to the specific device being investigated for this complaint record.Device history record (dhr) review was completed for the subject lot number: 1259848.No deviations or non-conformance's, which could have caused or contributed to the reported event, were noted as part of the dhr.Complaint history review was performed for the reported lot number: 1259848 for similar events and five (5) other complaints were identified.Review completed utilizing keywords: packaging damaged.The customer did submit four (4) images for the reported event.Based on the investigation and according to the capa, the most likely root cause determined from the investigation was external factors (temperature).This is an ongoing issue which is currently being monitored.Non conformance and health hazard evaluation have been opened to further contain affected products, evaluate potential root causes, and consider applicable corrective actions.Therefore, based on the available information, a packaging malfunction did occur.The implant's green cap was cracked while the green caps tamper seal was intact.The reported event/coob was confirmed.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.

• Brand Name: TSX IMPLANT, 3.1MMD, 8MML
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 20307856
• Report Number: 0001038806-2024-02171
• Device Sequence Number: 15674339
• Product Code: DZE
• UDI-Device Identifier: 00844868045038
• UDI-Public: (01)00844868045038(17)250110(10)1259848
• Combination Product (Y/N): N
• Initial Reporter Country: RO
• PMA/510(K) Number: K220978
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2025

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: Health Professional
• Device Expiration Date: 01/09/2025
• Device Catalogue Number: TSX31B8
• Device Lot Number: 1259848
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2024
• 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: 09/26/2024
• Supplement Report FDA Received Date: 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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 IMPLANT SEE H10 NARRATIVE.
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic