• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: PHILOS PLATE/SCREWS SCREW,FIXATION,BONE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SYNTHES GMBH UNK - CONSTRUCTS: PHILOS PLATE/SCREWS SCREW,FIXATION,BONE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Nerve Damage (1979); Non-union Bone Fracture (2369)
Event Type  Injury  
Manufacturer Narrative

Product complaint : (b)(4). Additional narrative: this report is for an unk - constructs: philos plate/screws/unknown lot. Part and lot numbers 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 as no product was received. The investigation could not be completed, no conclusion could be drawn at the time of filing this report. The product was not returned. 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.

 
Event Description

Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: rellán i. , et al (2021) time until union in absolute vs. Relative stability mipo plating in simple humeral shaft fractures, european journal of orthopedic surgery & traumatology volume xxxx, pages 1-7((b)(6)). This retrospective cohort study aims to evaluate the effect of absolute stability vs. Relative stability mipo plating on time to radiographic union in ao/ota 12a1 and a2 fractures of the humerus. From january 2007 to february 2020,216 patients surgically treated for a humeral shaft fracture with a plate were performed in a single level one trauma center. A total of 70 patients (52 females, 74 males) age 70 years (mean 52¿79) with humerus shaft fracture ao/ota type 12a1 & a2 were included in this study. Depending on the fixation technique, patients were categorized into two groups: as and rs, 35 patients in each group. A standard anterolateral humerus approach was used for all patients treated with an as construct. Depending on the location of the shaft fracture, different mipo approaches were used in the rs group. Three approaches were used in the rs group: lateral mipo (n = 19), anterior mipo (n = 9) and posterior mipo (n = 7). All fractures were fixed with either a proximal humerus internal locking system plate (philos®) (synthes ®, oberdorf, (b)(6) (n = 39) or a narrow locking compression plate (lcp) (synthes®, oberdorf, (b)(6)) (n = 31). In the as group, lag screws were used to achieve rigid internal fixation with either one (n = 16), two (n = 11), or three (n = 3) lag screws used. Five fractures were fixed using an lcp in compression mode without lag screws. Patients were followed with anteroposterior (ap) and lateral radiographs at 7 days, and every month thereafter until the union was achieved. The median follow-up was 9 (iqr 6¿14) months. The following complications were reported: five patients in the absolute stability (as) group presented with a primary radial nerve palsy, all of which recovered completely between 2 and 5 months post-operatively. Non-union was seen in two cases in the relative stability (rs) group. Both patients were successfully treated with revision surgery using an orif technique with the addition of allograft bone grafts. Three patients in the rs group operated through a posterior approach developed a postoperative radial nerve palsy. All of them recovered uneventfully without the need of additional surgeries. This report is for an unknown synthes proximal humerus internal locking system (philos®), and unknown synthes 4. 5 mm narrow locking compression plate (lcp). This report is for (1) unk - constructs: philos plate/screws. This report is 1 of 3 for (b)(4).

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNK - CONSTRUCTS: PHILOS PLATE/SCREWS
Type of DeviceSCREW,FIXATION,BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key11966977
MDR Text Key267330548
Report Number8030965-2021-04722
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeAR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,LITERATURE
Reporter Occupation
Type of Report Initial
Report Date 05/17/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/09/2021
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/17/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 06/09/2021 Patient Sequence Number: 1
-
-