MAUDE Adverse Event Report: SYNTHES GMBH 8.0MM TI USS CANC POLYAXIAL SCREW 70MM THREAD LENGTH; ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION

Model Number 04.607.280

Device Problem Mechanical Problem (1384)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

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.Additional device product codes: mni, kwq, nkb, kwp.Device available for evaluation: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The initial reporter is a j&j employee.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 Description

Device report from synthes reports an event in colombia as follows: it was reported that on an unknown date, the patient underwent surgery to implant the expedium sacroiliac uss.Then, the surgeon re-performed the procedure due to loosening of the iliac screws.The surgeon removed the 100mm screws and placed 70mm screws, keeping the same system of iliac connectors that the patient had placed in the initial surgery.This report involves one 8.0mm ti uss canc polyaxial screw 70mm thread length.This is report 2 of 2 for (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.H10 additional narrative: device history (lot), part: 04.607.280, lot : l873955, release to warehouse date : 02.Mar.2018, expiration date : na, supplier: na, manufacturing site: werk mezzovico.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Investigation summary: 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.

• Brand Name: 8.0MM TI USS CANC POLYAXIAL SCREW 70MM THREAD LENGTH
• Type of Device: ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico CO 6805 ; SZ 6805
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16523510
• MDR Text Key: 311079193
• Report Number: 8030965-2023-03049
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 10705034736570
• UDI-Public: (01)10705034736570
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K082572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.607.280
• Device Catalogue Number: 04.607.280
• Device Lot Number: L873955
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2018
• Patient Sequence Number: 1
• Treatment: 8.0MM TI USS CANC POLY SCR 70MM TRD LEN.
• Patient Outcome(s): Required Intervention
• Patient Age: 16 YR
• Patient Sex: Male