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

Device Problem Break (1069)

Patient Problems Pain (1994); Swelling (2091); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Report is for unknown plate.Part#, lot# and udi # is not available.Device is not expected to be returned for manufacturer review/investigation.This report is for unknown plate.Pma/510(k) number is not available.(b)(4).Product was not returned.Device history records review could not be completed without lot number.Based on the information available, it has been determined that no corrective and 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.[(b)(4)].

Event Description

This report is being filed after the review of the following journal article: pantalone, a.Et al (2015) from plate to nail: a case-report of proximal humerus non-union, injury, pages s48-s50 ((b)(6)).The present article reports a case of a (b)(6) man who developed an aseptic proximal humerus non-union treated initially with orif (philos® plate), bone substitute (orthoss®) and bone morphogenetic protein 7 (bmp-7).Due to implant failure, twelve weeks later the fixation was revised to titanium cannulated humeral nail.Osseous healing was noted 5 months later.The following complications were reported as follows: a (b)(6) male patient underwent stabilization of a proximal humerus fracture through open reduction and internal fixation with a philos plate 13 months previously.The patient then presented with ongoing left shoulder pain.The patient's functional capacity was reduced due to constant pain, especially during rotational movements of the arm and while trying to lift weights.The non-union scoring system (nuss) was calculated to be 20 points.The patient then underwent revision of the fixation.Twelve weeks after surgery, the patient felt a sharp intense pain while doing an external rotation movement of the left shoulder.The patient presented with his left forearm appearing flexed at the elbow (90°), with the arm adducted to the trunk and internally rotated at 45°.The left shoulder was swollen and painful with movements.The radiographs showed a failure of the plate fixation as seen in figure 5 where there is breakage of the plate at twelve weeks.The patient proceeded with a revision surgery.The plate and the screws were removed and following reduction stabilization was performed using a titanium cannulated humeral nail with a helical blade.Subsequent clinical and radiographic evaluation revealed osseous healing 5 months later.This report is for unknown lcp plate.This is report 3 of 3 for (b)(4).

• 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: 8222953
• MDR Text Key: 132341732
• Report Number: 8030965-2019-59507
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/12/2018

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2018
• Initial Date FDA Received: 01/07/2019
• 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: 40 YR
• Patient Weight: 70