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

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

Patient Problems Inflammation (1932); Loss of Range of Motion (2032); Swelling (2091); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown plate/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 (b)(6) 2020 the patient received debridement and suture under epidural anesthesia and kirschner wire internal fixation surgery for right foot pain and bleeding.On (b)(6) 2020, the patient was discharged without wound secretion and erythema inflammation.The patient came to our hospital for examination on (b)(6) 2020.Three days ago, several old surgical scars and two skin rubbing wounds were found on the right foot.After incision and contusion, the surrounding area was erythema inflammation.A rash was seen with a small amount of purulent fluid wound secretion.The swelling of the back of the foot was obvious, the skin temperature was slightly higher, the movement of the toes was limited, and no obvious abnormality was found in the other limbs.Therefore, removal of kirschner wire was performed for the patient.After surgery, the patient's condition is generally good, the signs are stable, the pain of the affected limb is improved, the incision has been opened, no wound secretion and erythema inflammation.This report is for one (1) unknown plate.This is report 2 of 3 for (b)(4).

• Brand Name: UNK - PLATES
• Type of Device: PLATE, FIXATION ,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 10587573
• MDR Text Key: 208581626
• Report Number: 8030965-2020-07448
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• 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: 09/01/2020
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR