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

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 02/01/2012

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown unk - plates: trauma/unknown lot number.Without the specific part number, the udi number and 510k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).The reported event required medical/surgical intervention to preclude permanent damage to a body structure and wound infection.Without a lot number, the device history records review could not be completed as no product was received.The investigation summary could not be completed; no conclusion could be drawn at the time of filing this report.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, 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

Device report from synthes reports an event in germany as follows: this report is being filed after the review of the following journal article: oe, k.Et al (2012), operative management of periarticular medial clavicle fractures¿report of ten cases, the journal of trauma and acute care surgery, vol.72 (2), pages e1-e7 (germany).The aim of this retrospective study is to analyze the operative treatment of periarticular, medial clavicle fractures at the trauma center murnau.Between january 2004 to july 2009, a total of 10 patients (9 males and 1 female), with a mean age of 33.9 years, were included in the study.Of these, only 9 patients were treated with either of the following: 2.7- to 3.5-mm small fragment locking plates, 2.7-mm lcp compact foot plate, lcp reconstruction plate, modified lcp pilon plate, or dynamic compression plate (dcp) (synthes, inc.).The mean follow-up time was 38 months (range, 14¿52 months).The following complications were reported as follows: a (b)(6) year-old male patient had plate loosening (pilon plate, non-locking screws were used), screws backed out and superficial wound infection 5 days after surgery.The plate was removed, and the operative site was treated using debridement and irrigation.The postoperative course remained without complications, and the wound remained dry and unremarkable.A (b)(6) year-old male patient was excluded from consecutive evaluation due to severe spinal cord injury with tetraplegia/paraplegia.The fracture healed, the patient did not have pain and were satisfied with the operative result.A (b)(6) year-old male patient was excluded from consecutive evaluation due to severe spinal cord injury with tetraplegia/paraplegia.The fracture healed, the patient did not have pain and were satisfied with the operative result.In one case of a young boy, early removal after 5 months was the result of local irritation, before operation fracture union was confirmed by ct scan (the article did not indicate specific implant used).These impacted products capture the reported (b)(6) year-old male patient who had plate loosening, screws backed out and superficial wound infection 5 days after surgery.The plate was removed, and the operative site was treated using debridement and irrigation.Medical history: motorcycle accident; left side displaced periarticular medial clavicle; fracture type 1b1.This report is for one (1) unknown synthes plate.This report is 1 of 4 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: 8808467
• MDR Text Key: 151632375
• Report Number: 8030965-2019-66414
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/26/2019

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: 06/26/2019
• Initial Date FDA Received: 07/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention