MAUDE Adverse Event Report: SYNTHES GMBH 4.5MM TI OCCIPITAL SCREW 14MM; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Catalog Number 04.601.114

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 11/27/2023

Event Type  Injury  

Event Description

Device report from japan reports an event as follows: it was reported that the patient underwent a posterior cervical fusion (o-c4) on (b)(6) 2023 that was completed successfully with no surgical delay.On (b)(6) 2023 the patient came to the outpatient clinic, where it was discovered that the two screws in question had loosened from the occipital bone.Revision surgery was scheduled for (b)(6) 2023 to replace the occipital bone plate and the bone screws in question.The cause of the loosening is unknown.No further information is available.This report is for a 4.5mm ti occipital screw 14mm.This is report 3 of 4 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d2: additional procodes: mnh, mni, kwp d9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.D10: date of concomitant therapy is (b)(6) 2023.E3: initial reporter is a synthes employee.G4: device is not distributed in the united states, but is similar to device marketed in the usa.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.

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.H3, h4, h6 the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that 4.5mm ti occipital screw 14mm appears to be in good condition.No defects were observed on the threaded portion of the screw.No issues nor malfunction that could have contributed to the reported event were observed.A dimensional inspection was not performed as it is not applicable to the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the observed condition of the 4.5mm ti occipital screw 14mm would not contribute to the complained event.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Drawing/specifications reviewed 04_601_104 rev.C current and manufactured dimensional inspection: n/a h4, h6 part # 04.601.114s lot # 9560057 manufacturing site: werk selzach logistik release to warehouse date: 03.July.2015 expiration date: 01.July.2025 supplier: früh verpackungstechnik ag a manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Non-sterile part # 04.601.114 non-sterile lot # 9510445 manufacturing site: werk mezzovico release to warehouse date: 02 june 2015 supplier: n/a 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: 4.5MM TI OCCIPITAL SCREW 14MM
• Type of Device: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK MEZZOVICO; via cavazz 5; mezzovico CO 6805 ; SZ 6805
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18346011
• MDR Text Key: 330731490
• Report Number: 8030965-2023-15840
• Device Sequence Number: 1
• Product Code: NKG
• UDI-Device Identifier: 10705034734323
• UDI-Public: (01)10705034734323
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• 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

• Date FDA Received: 12/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.601.114
• Device Lot Number: 9510445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: OCCIPIT-SCR ø4.5 L10 TAN.; OCCIPIT-SCR ø5 L12 TAN.; OCCIPITAL-PL 4.5/5 MED W/50 F/R ø4 TI.
• Patient Outcome(s): Required Intervention