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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - RODS ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

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SYNTHES GMBH UNK - RODS ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Nerve Damage (1979); Perforation of Vessels (2135); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
510k: this report is for an unk - rods: spine/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. Reporter is a j&j employee. (b)(4). 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 a clinical evaluation report (cer) from a database related research activity (drra) for a total of 431 patients (432 procedures) who were operated with depuy synthes implants against all other alif procedures recorded within the spine tango registry from (b)(6) 2005 to (b)(6) 2019. There were 276 females and 156 males with a mean age of 59 years. Since it was not specified in which country the adverse events have occurred, each country mentioned in the surgery activity namely: (b)(6) will be conservatively captured in separate product complaints: intraoperative surgical complications: (n
=
1) nerve root damage, (n
=
3) dural lesion, (n
=
4) vascular injury, (n
=
8) other, (n
=
8) unknown. Intraoperative general complications: (n
=
1) not documented, (n
=
8) unknown. Postoperative general complications: (n
=
1) cardiovascular, (n
=
1) pulmonary, (n
=
1) liver/gi, (n
=
7) not documented, (n
=
1) other, (n
=
8) unknown. Postoperative surgical complications: (n
=
6) other hematoma, (n
=
1) radiculopathy, (n
=
2) motor dysfunction, (n
=
1) sensory dysfunction, (n
=
2) implant failure, (n
=
7) not documented, (n
=
8) unknown, (n
=
1) implant malposition. Postoperative complications: (n
=
5) sensory dysfunction, (n
=
5) motor dysfunction, (n
=
2) bowel/bladder dysfunction, (n
=
1) non-union, (n
=
5) implant failure, (n
=
3) instability, (n
=
7) wound infection superficial, (n
=
1) wound infection deep, (n-
=
1) epidural hematoma, (n
=
1) extravertebral hematoma, (n
=
6) recurrence of symptoms, (n
=
3) adjacent segment pathology, (n
=
1) decompensation of spine, (n
=
3) fracture vertebral structures, (n
=
1) thromboembolism, (n
=
11) other, (n
=
1) implant malposition. Reoperations at any level: (n
=
5) hardware removal, (n
=
2) non-union, (n
=
5) instability, (n
=
2) failure to reach therapeutic goals, (n
=
1) postop deep infection, (n
=
5) implant failure, (n
=
2) adjacent segment pathology, (n
=
3) other, (n
=
16) unknown. Reoperations at same level: (n
=
3) hardware removal, (n
=
3) instability, (n
=
2) failure to reach therapeutic goals, (n
=
1) postop deep infection, (n
=
2) implant failure,, (n
=
2) adjacent segment pathology, (n
=
2) other, (n
=
4) unknown. This is for the unknown depuy synthes spine syncage, unknown depuy synthes spine syncage evolution, unknown depuy synthes spine synfix lr , unknown depuy synthes spine synfix evolution, unknown depuy synthes spine synex, unknown depuy synthese spine t-pal, unknown depuy synthese spine oracle, unknown depuy synthese spine tslp , unknown depuy synthese spine tab plate, unknown depuy synthese spine cslp, unknown depuy synthese spine uss, unknown depuy synthese spine chronos, unknown depuy synthese spine chronos putty, unknown depuy synthese spine vertecem , unknown depuy synthese spine vertecem v+, unknown depuy synthes spine matrix, unknown depuy synthes spine travis. , unknown depuy synthese spine peek rod. A copy of the clinical evaluation form is being submitted with this regulatory report. This report is for one (1) unk - cage/plate. This is report 2 of 14 for complaint (b)(4).
 
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Brand NameUNK - RODS
Type of DeviceORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
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 Key13666073
MDR Text Key289500189
Report Number8030965-2022-01333
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2022
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 Received06/10/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 03/04/2022 Patient Sequence Number: 1
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