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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 Cerebrospinal Fluid Leakage (1772); Hematoma (1884); Nerve Damage (1979); Non-union Bone Fracture (2369); Osteolysis (2377); Neck Pain (2433); Post Operative Wound Infection (2446)
Event Type  Injury  
Event Description
Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of a clinical evaluation report (cer) from a database related research activity (drra) for a total of 260 patients (268 procedures) who underwent posterior instrumentation (c0-th1) procedures between june 7, 2005 to september 15, 2021. There were 147 males and 121 females with a mean age of 62. 8 years. It was not specified in the spine tango registry report which of the devices mentioned have caused the adverse events. It was also not specified in which country the adverse events have occurred. Thus, each country mentioned in the surgery activity will be captured conservatively and complications will be reported as follows: 7 patients had intraoperative general complications: anaesthesiological (n
=
1). Other complications (n
=
2). 24 patients had postoperative general complications: cardiovascular (n
=
1), pulmonary (n
=
7), cerebral (n
=
2), kidney / urinary (n
=
3), liver / gi (n
=
1), death (n
=
2), and other compications (n
=
5). 7 patients had intraoperative surgical complications: dural lesion (n
=
3), vascular injury (n
=
2), other complications (n
=
1). 31 patients had postoperative surgical complications: epidural hematoma (n
=
2), other hematoma (n
=
2), radiculopathy (n
=
1), csf leak / pseudomeningocele (n
=
2), motor dysfunction (n
=
6), sensory dysfunction (n
=
3), bowel / bladder dysfunction (n
=
2), wound infection superficial (n
=
4), wound infection deep (n
=
2), implant malposition (n
=
1), other complications (n
=
4). 63 patients had a fair (n
=
52) and poor (n
=
11) outcome. 35 patients had postoperative complications: sensory dysfunction (n
=
6), motor dysfunction (n
=
4), non-union (n
=
4), implant failure (n
=
4), instability (n
=
2), wound infection superficial (n
=
1), extravertebral hematoma (n
=
2), implant malposition (n
=
1), recurrence of symptoms (n
=
2), graft complication (n
=
2), internal medicine (n
=
2), adjacent segment pathology (n
=
1), central nervous system (n
=
1), other (n
=
3). 25 patients had reoperations at any level due to: adjacent segment pathology (n
=
1), hardware removal (n
=
3), implant failure (n
=
3), instability (n
=
1), neurocompression (n
=
2), other reasons (n
=
4). 3 patients had reoperations at same level due to: hardware removal (n
=
2), neurocompression (n
=
1), other reasons (n
=
1). This is for unknown depuy synthes spine constructs: plate/screws. This is report 11 of 12 for (b)(4).
 
Manufacturer Narrative
Additional narrative: 510k: this report is for an unknown constructs: plate/screws/unknown lot. Part and lot number are unknown. Without the specific part number; the udi number and 510-k number is unknown. Reporter is a j&j employee. 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.
 
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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 Key14316624
MDR Text Key292733845
Report Number8030965-2022-03014
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 Foreign,Study
Reporter Occupation Other Health Care Professional
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2022
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 Received04/07/2022
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: 05/07/2022 Patient Sequence Number: 1
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