MAUDE Adverse Event Report: SYNTHES GMBH UNK - SCREWS: CERVIFIX; SCREW, FIXATION, BONE

Catalog Number UNK - SCREWS: CERVIFIX

Device Problem Material Integrity Problem (2978)

Patient Problems Neck Pain (2433); Decreased Sensitivity (2683)

Event Type  Injury  

Event Description

Device report from synthes reports an event in brazil as follows: it was reported that the patient underwent surgical treatment procedure for correction of craniocervical malformation on (b)(6) 2017.After occipital cervical fixation (c2 and c3), there was a progressive improvement in symptoms and sensitivity.Approximately 45 days ago, after severe coughing, he presented neck pain and worsening of sensory-motor symptoms.Investigation with cervical spine mri and cervical spine tomography showed the fracture of a cervical nail and a screw.This report is for one (1) unk - screws: cervifix this is report 1 of 2 for complaint (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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.Additional narrative: this report is for an unk - screws: cervifix /unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.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.

• Brand Name: UNK - SCREWS: CERVIFIX
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15454652
• MDR Text Key: 300224926
• Report Number: 8030965-2022-07103
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK - SCREWS: CERVIFIX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ROD Ø3.5 L120 TAN GOLD; UNKNOWN NAILS
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Sex: Male