MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - RODS: CLICK'X; ROD, FIXATION, INTRAMEDULLARY

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

Patient Problems Hypersensitivity/Allergic reaction (1907); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown rod/unknown lot.Part and lot number 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.(b)(4).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 (b)(6) reports an event as follows: it was reported that on an unknown date that the customer was implanted with a click¿x system.The patient was inquiring about the material composition of the click¿x system because she is suffering from a known allergy against manganese.The patient needs further treatment, possibly with expedium si system.This report is for one (1) unknown rod.This is report 1 of 3 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.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

Concomitant devices reported: unk - mono/polyaxial screws: click'x' (part# unknown, lot# unknown, quantity# 1), unk - locking/set screws: click'x (part# unknown, lot# unknown, quantity# 1).This report is for one (1) unknown rods: click'x.

• Brand Name: UNK - RODS: CLICK'X
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10179876
• MDR Text Key: 197106658
• Report Number: 8030965-2020-04354
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/15/2020

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/15/2020
• Initial Date FDA Received: 06/22/2020
• Supplement Dates Manufacturer Received: 07/06/2020
• Supplement Dates FDA Received: 07/14/2020
• Patient Sequence Number: 1
• Treatment: UNK - LOCKING/SET SCREWS: CLICK'X; UNK - MONO/POLYAXIAL SCREWS: CLICK'X'
• Patient Outcome(s): Required Intervention