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

Device Problem Failure to Align (2522)

Patient Problem No Code Available (3191)

Event Date 10/21/2006

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown plates: trauma/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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.Investigation summary: the investigation could not be completed; no conclusion could be drawn, as no product was received.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.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

Device report from synthes reports an event in germany as follows: this report is being filed after the review of the following journal article: kettler, m et al (2006).Treatment of proximal humeral fractures with the philos angular stable plate presentation of 225 cases of dislocated fractures.Der unfallchirurg 12.Volume 109.Pages 1032-1040.(germany).The aim of the present study was therefore to determine the functional treatment results for patients with dislocated humeral head fractures after angular stable plate osteosynthesis (philos, synthes®, germany) in a larger number of patients, using the constant score, and to compare them with radiological criteria such as fracture type and fracture reduction.From january 2002 to august 2005, 223 patients (152 women and 71 men with an average age of 66+/-15 years) with 225 dislocated humeral head fractures were included in this study.All patients were treated with an unknown synthes proximal humeral internal locking system angular stable plate.176 of 225 fractures (123 women and 51 men) were clinically and radiologically examined.17 patients had died within the first postoperative years from causes not related to surgery, 9 could not be adequately evaluated due to being bedridden or suffering from dementia, and 6 patients did not want to be re-examined.During follow-up, the aim was to examine the patients postoperatively at defined points in time (6 weeks, 3 months, 6 months, 9 months, 12 months and 24 months) and to assess the shoulder function using the constant score.The postoperative x-ray images of the 225 osteosyntheses in at least 2 planes were evaluated.Complications were reported as follows: unknown patients had primary screw perforation as well as further implant dislocations.Unknown patients had plate dislocations out of the shaft.Unknown patients had humeral head collapse with secondary screw perforation.Unknown patients had screw perforations into the glenohumeral joint.Unknown patients had total avascular humeral head necrosis.Unknown patients had partial humeral head necrosis.The following complications are stated in table 1: a (b)(6) year-old male had wound infection with single revision.A (b)(6) year-old male had wound infection and 2 revisions with implant removal.A (b)(6) year-old female had multiple primary screw perforations with removal of multiple screws.A (b)(6) year-old male had shaft dislocation, plate revision, heterotopic ossification, and implant removal.A (b)(6) year-old female had primary tubercle dislocation, correction, debridement in case of infection, partial me, and partial necrosis.An (b)(6) year-old male had malfixation with screw dislocation, implant removal, and healing in dorsal buckling.A (b)(6) year-old female had screw dislocation from the stem.A (b)(6) year-old female had implant dislocation from the stem.The patient had plate revision.An (b)(6) year-old female had implant dislocation in stem fracture.The plate was revised.The patient died.An (b)(6) year-old female had implant dislocation after fall from the stem.The patient had a revision with plate change.A (b)(6) year-old female had implant dislocation.The patient had implant removal; varus faulty healing.A (b)(6) year-old female had plate fracture in pseudarthrosis subcapital.The patient had plate change; healed.A (b)(6) year-old female had secondary tubercle dislocation and underwent tubercle revision.A (b)(6) year-old male had secondary tubercle dislocation and underwent revision.An (b)(6) year-old female had an incorrect reduction and sintering with screw perforation.The patient had implant removal and revision.A (b)(6) year-old male had incorrect reduction and sintering with screw perforation.The patient had implant removal and arthrodesis.An (b)(6) year-old female had sintering with secondary overhang and implant removal.The patient had necrosis.An (b)(6) year-old male had sintering with cranial screw dislocation.The patient had implant removal and minor varus faulty healing.A (b)(6) year-old female had sintering with screw perforation.A (b)(6) year-old male had sintering with screw perforation, implant removal, minor varus position, and partial necrosis.A (b)(6) year-old female had sintering with screw perforation, implant removal, and humeral head necrosis.A (b)(6) year-old male had sintering with screw perforation, implant removal, and humeral head necrosis.A (b)(6) year-old female had sintering with screw perforation, implant removal, and humeral head necrosis.A (b)(6) year-old female had sintering with screw perforation, implant removal, and humeral head necrosis.A (b)(6) year-old male had sintering with screw perforation, implant removal, varus position, and partial necrosis.A (b)(6) year-old female had sintering with screw perforation and underwent implantation: hemiprosthesis.A (b)(6) year-old male had sintering with screw perforation and underwent implantation: inverse prosthesis.The patient died.A (b)(6) year-old female had sintering with screw perforation and underwent implantation: inverse prosthesis.A (b)(6) year-old female had humeral head necrosis and implant removal.The patient underwent secondary hemiprosthesis.This report is for two (2) devices- unknown synthes proximal humeral internal locking system plates and screws.This report is for one (1) unknown plate, these impacted products capture the reported (b)(6) year-old female had implant dislocation after fall from the stem.The patient had a revision with plate change.This is report 7 of 8 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 ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 6103142063
• MDR Report Key: 8323395
• MDR Text Key: 135882981
• Report Number: 8030965-2019-60836
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2019
• 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
• Date Manufacturer Received: 01/21/2019
• 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