MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: USS MIS; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

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)

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 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: uss mis.This report is 15 of 20 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).510k: this report is for an unk - constructs: uss mis/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.

• Brand Name: UNK - CONSTRUCTS: USS MIS
• Type of Device: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• MDR Report Key: 12607981
• MDR Text Key: 281505501
• Report Number: 8030965-2021-08566
• Device Sequence Number: 1
• Product Code: NKG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• 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 Received: 10/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/13/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention