MAUDE Adverse Event Report: SYNTHES GMBH MANDIB-CORTSCR Ø2 SELF-TAP L6 TI; SCREW, FIXATION, BONE

Catalog Number 411.906S

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

Patient Problems Fatigue (1849); Hypersensitivity/Allergic reaction (1907); Loss of consciousness (2418)

Event Date 10/13/2011

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.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.The initial reporter is a j&j employee.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.

Event Description

Device report from synthes reports an event in russia as follows: event description: a customer has requested the information metal content of the following implants: 447.100, 411.906 and 411.910.Item lot number data is not available / not saved.The request was received in connection with the discovery of an excess of aluminum in the patient's body.A decision is made to remove the implants.The surgery was done in 2011.Date of detection of high aluminum content: (b)(6) 2021.The patient found an increase in aluminum levels through a laboratory blood test as part of a health check.The patient purchased the implants at the own expense.Symptoms that the patient is currently experiencing: blurred consciousness, fatigue.The client is worried, because the excess of 6 times aluminum is a high risk of developing dementia and alzheimer's disease.Were the implants already explanted? no, the need for explantation was associated with a suspected effect of the medical devices on the increase in the content of aluminum in the patient's blood, but it was found that these medical devices do not contain aluminum in the composition.This report is for one (1) mandib-cortscr ø2 self-tap l6 ti.This is report 4 of 7 for complaint (b)(4).

• Brand Name: MANDIB-CORTSCR Ø2 SELF-TAP L6 TI
• 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: 15906451
• MDR Text Key: 304727231
• Report Number: 8030965-2022-10571
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07611819169463
• UDI-Public: (01)07611819169463
• Combination Product (y/n): N
• Reporter Country Code: RS
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 411.906S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ADAPTPL 2 20HO SPACE5 TI.; MANDIBLE-CORTSCR Ø2 SELF-TAP L10 TI.; MANDIBLE-CORTSCR Ø2 SELF-TAP L10 TI.; MANDIBLE-CORTSCR Ø2 SELF-TAP L10 TI.; MANDIBLE-CORTSCR Ø2 SELF-TAP L10 TI.
• Patient Outcome(s): Required Intervention