MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH; PLATE, FIXATION, BONE

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: device was used for treatment, not diagnosis.Patient date of birth and weight not available for reporting.Date of event is unknown; occurred in 2017.510k: this report is for an unknown implants.Part and lot numbers are unknown; udi number is unknown.Devices were implanted on an unknown date in (b)(6) 2017, devices remain implanted.Devices are not expected to return for investigation.No facility information was available.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 (b)(4) reports an event in chile as follows it was reported on (b)(6) 2017, that a patient who was implanted with unknown synthes implants in (b)(6) 2017, has been experiencing signs of an allergic reaction sustained over a period of time.The devices remain implanted in the patient.(b)(4).This report is for an unknown quantity of unknown synthes implants.

Manufacturer Narrative

Additional patient identifier: (b)(6).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 europe reports an event in (b)(6) as follows: it was reported that a patient who was implanted with 15 unknown implants from a locking compression system, titanium foot on (b)(6) 2017, experienced a post-operative allergic reaction several months after the initial surgery.Medical intervention was provided to the patient as tests (unspecified) were positive for a reaction to the implanted material.It is unknown if the devices were explanted.

Manufacturer Narrative

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.

• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): OBERDORF : SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7154039
• MDR Text Key: 96026394
• Report Number: 8030965-2017-51002
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: CI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR