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U.S. Department of Health and Human Services

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

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SYNTHES GMBH UNK - CONSTRUCTS: PLATE/SCREWS PLATE, FIXATION, BONE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Ossification (1428); Arthritis (1723); Necrosis (1971); Nerve Damage (1979); Post Operative Wound Infection (2446); Insufficient Information (4580)
Event Type  Injury  
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803. This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date. This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report. If the information is unknown, not available or does not apply, the section/field of the form is left blank. This report is for an unknown device/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. 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: jang, j. H. Et al. (2021), surgical outcomes of transverse acetabular fractures and risk factors for poor outcomes, bmc musculoskeletal disorders, vol. 22:222, pages 1-9 (south korea). This study aimed to verify the surgical outcomes of the transverse acetabular fracture and its subtypes and to investigate prognostic factors for poor surgical outcomes. Between 2014 and 2019, 39 patients (23 males and 16 females with a mean age of 41. 7 years (range, 18¿78 years)) underwent open reduction and internal fixation (orif) for an acetabular fracture using 3. 5 reconstruction plates (titanium; depuy synthes, oberdorf, switzerland) and/or 3. 5 lowprofile pelvic plates (stainless steel; depuy synthes). The mean follow-up period was 23. 2 months (range, 12. 0¿51. 5 months). The article does not identify which specific depuy synthes product ( 3. 5 reconstruction plates and/or 3. 5 lowprofile pelvic plates) is associated with the adverse event(s). The following complications were reported as follows: 3 patients had postoperative infections that required surgical debridement. 2 patients experienced a neurologic deficit of the peroneal part of the sciatic nerve after injury. 1 patient had an iatrogenic injury of the lateral cutaneous femoral nerve. All patients recovered from nerve injuries within 1 year. 16 patients had heterotopic ossifications, including eight cases categorized as class i, three as class ii, four as class iii, and one as class iv according to brooker classifications. 11 cases were diagnosed with osteoarthritis acompanied by osteonecrosis of the femoral head. Five underwent tha. 15 patients had an imperfect quality of reduction and 10 patients had poor quality of reduction. This report is for an unk - construct: plate/screws. This is report 1 of 1 for (b)(4).
 
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Brand NameUNK - CONSTRUCTS: PLATE/SCREWS
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key15084626
MDR Text Key296391625
Report Number8030965-2022-05086
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeKS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2022
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? Yes
Date Manufacturer Received06/23/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 07/22/2022 Patient Sequence Number: 1
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