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U.S. Department of Health and Human Services

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

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SYNTHES GMBH UNK - CONSTRUCTS: PHILOS PLATE/SCREWS PLATE, 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); Pain (1994); Deformity/ Disfigurement (2360); Non-union Bone Fracture (2369)
Event Type  Injury  
Manufacturer Narrative

This report is for an unknown philos plate and screws construct/unknown lot. Part and lot number are unknown. Without the specific part number; the udi number and 510-k 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. 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 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

This report is being filed after the review of the following journal article: robinson, c. M. Et al. (2020), open reduction and long locking plate fixation of complex proximal humeral metadiaphyseal fractures, the journal of bone and joint surgery, vol. 102-a, number 24, pages 2146-2156 (united kingdom). The aim of this study was to evaluate the outcomes and risk of complications in patients with these injuries, treated by a protocol of open reduction and long locking plate fixation (lpf). Between 2007 and 2014, a total of 102 patients underwent open reduction and long locking plate fixation (lpf). There were 37 males and 65 females with a mean age of 58. 0 years. The philos plate (synthes) was used, with 12 diaphyseal holes (268 mm) in 50 cases, 10 holes (232 mm) in 28, and 8 holes (196 mm) in 24. Supplementary tuberosity suture or screw fixation was used in 18 cases. Outcomes were prospectively recorded at follow-up appointments at 6 weeks, 3 and 6 months, and 1 and 2 years postoperatively. The following complications were reported as follows: 18 patients died. 8 patients developed developed superficial wound infections which resolved after broad-spectrum oral antibiotic therapy. 3 patients had early fixation failure: 1 of these patients sustained a periprosthetic fracture distal to the tip of the plate in a fall 2 weeks postoperatively and was successfully treated by revision lpf and autogenous bone grafting. 1 declined additional surgery, underwent nonoperative treatment, and demonstrated union at the 1-year assessment. 1 patient demonstrated lpf failure at 6 weeks postoperatively. Revision lpf with autogenous bone grafting failed, and the patient was treated with a long-stem total shoulder arthroplasty. 4 patients developed nonunion of the diaphyseal segment, without evidence of fixation failure. All underwent revision with curettage at the nonunion site, lpf revision with compression, and autogenous bone-grafting between 6 and 9 months postoperatively, and all fractures healed without additional surgical intervention. 1 patient had radial nerve palsy, which resolved by 3 months after the revision surgery. 7 patients had painful postsurgical stiffness at the 6-month clinical assessment, but 4 declined intervention or were medically unfit for additional surgery. Arthrolysis, subacromial decompression, and implant removal (adrom) was performed in 3 patients at a mean of 8 months (range, 6 to 14 months) and no further intervention was subsequently required. 8 patients underwent a solitary reoperation in the first 2 years, and 1 underwent 2. At the final 2-year follow-up of 102 patients, 98 patients had a humeral head angular deformity of <10 degrees and the remaining 4 had a varus deformity of 10 degrees to 20 degrees. Ninety-nine patients had humeral shaft angulation of <10 degrees , and 3 had angulation of between 10 degrees and 15 degrees. This report is for an unknown synthes philos plate and screws construct. This report captures the reported events of nonunion, radial nerve pals, painful postsurgical stiffness, solitary reoperation, revision surgery, humeral head angular deformity of <10 degrees, varus deformity of 10 degrees to 20 degrees, humeral shaft angulation of <10 degrees and angulation of between 10 degrees and 15 degrees. This is report 3 of 3 for (b)(4).

 
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Brand NameUNK - CONSTRUCTS: PHILOS PLATE/SCREWS
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key11967592
MDR Text Key267264547
Report Number8030965-2021-04734
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
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
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