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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES USA PLATE, FIXATION, BONE

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SYNTHES USA PLATE, FIXATION, BONE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Ossification (1428); Bone Fracture(s) (1870); Osteolysis (2377); Impaired Healing (2378); No Code Available (3191)
Event Date 03/20/2017
Event Type  Injury  
Manufacturer Narrative
Device used for treatment, not for diagnosis. The investigation could not be completed; no conclusion could be drawn, as no device was returned and no lot number or part number was provided. (b)(4). 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 subsequent review of the following article: erdle, b; et al (2017) comparative analysis of locking plate versus hook plate osteosynthesis of neer type iib lateral clavicle fractures. Arch orthop trauma surg, 137:651-662. This retrospective, observational cohort study to analyze and compare clinical and radiological results and complications of locking plate osteosynthesis (lpo) versus hook plate osteosynthesis (hpo) with acromioclavicular joint (acj) stabilization. For lpo, either a 3. 5 mm lcp t-plate (depuy synthes) designed for distal radius fractures or lcp superior lateral clavicle plate (depuy synthes) was used. For hpo, a 3. 5 mm lcp clavicular hook plate (depuy synthes, west chester, usa) was used. There were 32 patients (19 hpo, 13 lpo) with a mean age of 44. 1±14. 2 years at surgery. The mean follow-up period was 54. 2 months (range 25. 2¿111. 4 months). Hpo complications included 1 non-union with no revision, 2 delayed unions, 1 peri-implant fracture with revision, 5 persistent acromial osteolysis and 8 posttraumatic acj arthrosis. Lpo complications included 3 delayed unions, 1 post traumatic acj arthrosis. Heterotopic ossifications in the coracoclavicular region were present in 12 patients (37. 5%) (n
=
9 hp, n
=
3 lp; p
=
0. 21) and did not influence functional outcome measures. This is 1 of 1 for (b)(4). This report is for an unknown lcp plate and refers to the serious injury of 1 unknown patient who experienced non-union, 5 delayed unions, 1 peri-implant fracture with revision, 5 persistent acromial osteolysis, 9 posttraumatic acj arthrosis and 12 heterotopic ossifications.
 
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Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
SYNTHES USA
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6971085
MDR Text Key90038267
Report Number2520274-2017-12517
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
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 10/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/24/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/05/2017
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: 10/24/2017 Patient Sequence Number: 1
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