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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: 1303 GOSHEN SYNTHES USA PRODUCTS LLC UNK - CONSTRUCTS: SYNAPSE ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

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1303 GOSHEN SYNTHES USA PRODUCTS LLC UNK - CONSTRUCTS: SYNAPSE ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD Back to Search Results
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
Patient Problems Bone Fracture(s) (1870); Perforation of Vessels (2135); Unspecified Tissue Injury (4559)
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). This report is for an unk - constructs: synapse /unknown lot. Part and lot numbers are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review/ investigation. Reporter is a j&j representative. Without a lot number, the device history records review could not be completed as no product was received. The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report. The product was not returned. Based on the information available, it has been determined that no corrective and 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
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 related research activity database (ddra) for patients who were treated with depuy synthes spine llif. The following complications have been identified as per the spine tango report: 2 patients died. Interop general complications: 2 complications were not documented. Interop adverse events: 6 complications were dural lesions. 2 complications were vascular injury. 2 complications were fracture vertebral structures. 2 were other complications. Postop general before discharge: 3 complications were cardiovascular. 1 complication was pulmonary. 1 complication was thromboembolism. 3 complications were not documented. Postop surgical before discharge: 1 complication was sensory dysfunction. 1 complication was wound infection superficial. 11 were other complications. 3 complications were not documented. Reoperations: 4 patients had reoperations. This report is for an unknown acis, cervios, cervios chronos, chronos, cslp, facet wedge, ecd, matrix, opal, oracle, steno fix, synapse, synex, synfix evolution, synflate, synmesh, t-pal, uss small stature, uss, uss fracture, uss fx mis, vectra, vbs, vertecem, xrl, zero-p, zero-p va. This report is for (1) unk - constructs: synapse. This report is 7 of 20 for (b)(4).
 
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Brand NameUNK - CONSTRUCTS: SYNAPSE
Type of DeviceORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
Manufacturer (Section D)
1303 GOSHEN SYNTHES USA PRODUCTS LLC
1303 goshen parkway
west chester PA 19380
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12606205
MDR Text Key279283221
Report Number2530088-2021-00023
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
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
Report Date 09/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/11/2021
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/13/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 10/11/2021 Patient Sequence Number: 1
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