MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXP TI POLY SCREW 8MMX75MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number	179712875
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
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.H11: additional narrative: a1: patient identifier added.A2: date of birth & patient age at the time of event added.A3a: sex added.A4: weight of the patient added.B5: event description added.D6a: implantation day/month/year added.H4: manufacturer date added.H6 component codes: most relevant component code is g07002 (appropriate term/code not available) to capture no findings available due to no product returned.H3, h6: 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 history review (dhr): product code: 179712875, lot number: rl301117, release to warehouse date: 18 feb 2022, expiration date: na, supplier: (b)(4), manufacturing site: medos int.Spine.A manufacturing record evaluation was performed for the finished article lot and no non-conformance's were identified.Corrected data: d4: primary udi number updated.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, follow-up medwatch will be filed as appropriate.
Event or Problem Description
Additional information received states that the screws were removed and the clinical findings was broken bilateral illiac screws with no laboratory test taken.
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.H11 additional narrative: d4: udi: the manufacturing date is currently not available.Therefore, the full udi is currently not available.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j sales representative.H3, h6: 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
It was reported that on (b)(6) 2024, the two broken screws were removed from a patient.No further information is provided.This report is for one (1) exp ti poly screw 8mmx75mm.This is report 2 of 2 for complaint (b)(4).

• Brand Name: EXP TI POLY SCREW 8MMX75MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 8472871282
• MDR Report Key: 20069493
• Report Number: 1526439-2024-02147
• Device Sequence Number: 20741969
• Product Code: NKB
• UDI-Device Identifier: 10705034068138
• UDI-Public: (01)10705034068138(10)RL301117
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 179712875
• Device Lot Number: RL301117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/29/2024
• Supplement Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 08/26/2024
• Supplement Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/18/2022
• 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: EXP TI POLY SCREW 8MMX75MM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 95 KG