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U.S. Department of Health and Human Services

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

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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 Muscular Rigidity (1968); Nerve Damage (1979); Malunion of Bone (4529)
Event Type  Injury  
Manufacturer Narrative

Product complaint # (b)(4). 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: sun q, et al. (2020), plate fixation versus arthroscopic-assisted plate fixation for isolated medium-sized fractures of the greater tuberosity: a retrospective study, orthopedic surgery, volume 12, number 5, pages 1456-1463, (china). The present study aimed: (i) to evaluate the effectiveness of arthroscopic-assisted plate fixation (aspf) in patients with displaced isolated medium-sized fractures of the greater tuberosity; (ii) to compare the functional outcomes of aspf versus open reduction and internal plate fixation (orif); (iii) to assess the rate of complications between aspf versus orif in the treatment of displaced isolated medium-sized fractures of the greater tuberosity. From july 2013 to october 2017, 46 patients with displaced isolated medium-sized fractures of the greater tuberosity who underwent arthroscopic-assisted plate fixation (aspf group) or open reduction and internal plate fixation (orif group). There were 19 patients in the aspf group and 27 patients in the orif group. The average age of patients was 49. 4 +/-12. 1 years in the aspf group and 46. 9 +/- 11. 4 years in the orif group. There were 13 men and 6 women in the aspf group, and 20 men and 7 women in the orif group. All patients in the orif group were implanted with an unknown synthes proximal humerus internal locking system plate (philos) along with braided sutures that were tied to the plate through the suture eyelets for supplemental fixation of the greater tuberosity fracture. Meanwhile, patients in aspf group were implanted with a competitor¿s device. The postoperative rehabilitation regime was similar for the aspf and orif groups. The affected upper extremity was supported by a sling bandage for 4 weeks after surgery. The patients were allowed to begin passive exercises from the second postoperative day. The active assistant exercises were initiated from 6 weeks after surgery. Active resistance exercises were usually started 3 months postoperatively or when radiographic evidence showed fracture healing. The mean follow-up was similar for the aspf (19. 4 +/- 3. 7 months) and the orif (18. 2 +/-3. 2 months) groups. Complications were reported: 2 patients had postoperative shoulder stiffness. Shoulder stiffness were manipulated to release adhesion under anesthesia. Patient¿s obtained satisfactory shoulder function after manipulation, based on their self-evaluation. 2 patients had fracture malunion. Patients underwent reoperation, and stable fixation and bone union was achieved. 1 patient had subacromial impingement. The patients had subsequent relief of impingement symptoms after removal of the plate. This report is for the unknown synthes proximal humerus internal locking system plate (philos). This report is for (1) unk - constructs: philos plate/screws. This report is 1 of 1 for (b)(4).

 
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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 Key11978477
MDR Text Key267544095
Report Number8030965-2021-04796
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,LITERATURE
Reporter Occupation
Type of Report Initial
Report Date 05/19/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/10/2021
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 Received05/19/2021
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: 06/10/2021 Patient Sequence Number: 1
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